Effects of a multi-strain Bacillus probiotic on the intestinal microbiome, haemato-immunology, and growth performance of Nile tilapia.

The study evaluated dietary supplementation with a feed additive composed of multi-strain Bacillus for Nile tilapia Oreochromis niloticus. In vitro and in vivo assays employing culture-based microbiological methods and metagenomics were performed. Additionally, the study assessed the haemato-immunology, intestinal microbiome, and growth performance of the animals. For this, 30 juvenile Nile tilapia were used in the in vitro assay and 180 (60 + 120) in the in vivo assays. In the in vitro assay, we found evidence of adhesion of the probiotic bacteria to the intestinal mucus of fish, corroborated in the 15-day in vivo assay, in which the count of B. licheniformis was significantly higher in fish fed with probiotic when compared to fish of the control group. Furthermore, in the 50-day in vivo trial, a metagenomic analysis provided evidence for the modulation of the intestine microbiome of Nile tilapia by dietary supplementation of the probiotic. In addition, there was an increase in species richness, higher abundance of potentially probiotic autochthonous species and a lower abundance of Aeromonas sp. when the animals were fed the supplemented diet. Finally, no significant differences were observed in growth performance and haemato-immunological analyses, suggesting no harm to fish health when the product was supplemented for 15 and 50 days. The in vitro results indicate that the multi-strain probiotics were able to adhere to the intestinal mucus of Nile tilapia. Additionally, a modulation of the intestinal microbiome was evidenced in the in vivo assay.

Sodium dodecylbenzene sulphonate (SDBS) present in detergents: action on the gills, skin, and blood of D. rerio fish.

1. Sodium dodecylbenzene sulphonate (SDBS) is one of the surfactants used worldwide in detergents which, due to high residual discharges, has great potential to cause ecotoxicological impacts. Therefore, the sublethal effects of SDBS on the gills and skin of male Danio rerio fish were investigated.2. The fish were distributed into three groups: GC (control), GT1 (0.25 mg/L of SDBS), and GT2 (0.5 mg/L of SDBS) and exposed for 21 days. After the experiment, histopathological analyses of the gills, histochemical analyses (counting of mucous cells), and biochemical analyses (antioxidant defense enzyme analysis, SOD, and CAT) were conducted.3. A significant increase (p < 0.05) in the incidence of circulatory disorders, progressive, and regressive alterations occurred in the GT1 and GT2 groups. Due to these changes, the total histopathological index of the gills was higher in these groups. Mucous cells in the gills and skin increased. There was an increase in SOD activity and a reduction in CAT activity in these groups. Haematology revealed neutrophilia and lymphocytosis in the blood of GT1 and GT2.4. The results clearly demonstrate that a 21-day exposure to SDBS causes severe morphophysiological damage to the gills, skin, and blood of D. rerio fish.

Anaemia among school children of different socioeconomical status in a city of Southern Brazil.

Background: Iron deficiency is one of the leading causes of anaemia, with those most affected being children and women of childbearing age, in Brazil there is a scarcity of studies involving the local prevalence of anaemia. Aim: To evaluate anaemia and associated factors in schoolchildren in Santa Cruz do Sul through the analysis of biochemical and haematological markers and parasitological examination of faeces. Subjects and methods: School children from 10 to 12 years of age were evaluated through complete blood count, serum ferritin, C-reactive protein and stool parasitological examination, as well as socio-demographic characteristics and prophylaxis with ferrous sulphate in childhood. Results: It was found that 13.0% of the population was anaemic, girls were very slightly overrepresented among the anaemic children. Only 5.3% had altered haematocrit levels; 26.6% had low Mean Corpuscular Volume levels; 18.4% had low ferritin levels; 2.4% had increased C-reactive protein levels, and 21.7% had altered eosinophils. As for the socioeconomic level, classes A2 and D presented lower haemoglobin levels, as well as class D presenting lower ferritin levels, although without statistical significance. Only 6.0% of the population presented iron-deficiency anaemia and 46.0% of the schoolchildren had used ferrous sulphate supplementation in childhood. Conclusion: The prevalence of anaemia in the studied municipality is low, probably due to the high municipal human development index. Epidemiological studies are essential to characterise the population in a systematic form, to prevent future problems.

Anaemia in South American camelids - an overview of clinical and laboratory diagnostics.

South American camelids (SACs) play an increasing role in veterinary care in Europe. Many alpacas or llamas presented to veterinarians suffer from anaemia, regularly with a packed cell volume (PCV) below 0.10 l/l, which is a life-threatening condition for the animals. This review article presents clinical and laboratory diagnostic tools for the diagnosis of anaemia in SACs. Clinical identification of anaemic animals can be performed by assessing the FAMACHA© score and the Body Condition Score (BCS), since anaemia in alpacas and llamas correlates with pale mucous membranes and a lowered BCS. Haematological examination of a blood sample can provide a more differentiated diagnosis of anaemia in SACs. A common finding is regenerative anaemia with an increased number of reticulocytes that is often caused by blood loss due to Haemonchus contortus. Changes in a blood smear from an alpaca or llama with regenerative anaemia may include normoblasts (nucleated red blood cells), anisocytosis, poikilocytosis, polychromasia, Howell-Jolly bodies or basophilic stippling. Furthermore, non-regenerative anaemia, often caused by trace element deficiency or cachexia, can also occur.

Haematology and biochemistry in healthy llamas at sea level.

In the last years, there has been an increasing interest in llamas, not only as part of a productive system, but mostly as companion animals. Most reports regarding clinical biochemistry and haematology include few llamas and details about their health status are not available. The present study aims to provide haematological and biochemical parameters for llamas of known health status. Twenty-three non-pregnant females and seven males that live in Buenos Aires, Argentina (34°36'S, 58°22'W, at sea level) were studied. Llamas were clinically healthy, in good nutritional status. Animals were kept at grass and were fed hay bale or pellets and water ad libitum. Blood samples were collected by jugular venipuncture in spring. Packed cell volume, leucocyte count, differential white cell count, platelets count, urea, creatinine, total proteins, albumin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, glucose, calcium and phosphate were assessed. No significant differences were observed between males and females, except for platelet count and calcium, which was greater in males (P˂0.01). Values obtained for the different parameters were similar to those previously reported, except for monocytes, alkaline phosphatase, glucose and calcium, that were lower and lymphocytes and platelets count, that were higher in this study. In conclusion, different ambient and methodological conditions might affect some parameters. The parameters hereby presented are representative of llama's population living at sea level in South America.

Haemophagocytic syndrome caused by disseminated nontuberculous mycobacterial infection.

A female patient in her 30s presented to the emergency department with a 10-day history of fever, weakness and diaphoresis. Subsequent investigations revealed a diagnosis of haemophagocytic syndrome, secondary to disseminated non-tuberculous mycobacterial infection affecting the bone marrow, lungs, lymph nodes and skin. The bone marrow culture confirmed the presence of Mycobacterium avium infection. The patient's haemophagocytic syndrome was managed using the HLH-2004 chemoimmunotherapy, and M. avium infection was treated with a combination of clarithromycin, ethambutol, rifampicin, ciprofloxacin and amikacin. Throughout her hospitalisation, the patient faced several serious complications arising from both the medications and the prolonged hospital stay (lasting 12 months). However, these complications were promptly identified and effectively managed through a multidisciplinary and comprehensive approach. This approach was crucial in achieving a favourable patient outcome and successful recovery.

Developing a partnership to improve health care delivery to children <18 years with cancer and blood disorders in the English-speaking Caribbean: lessons from the SickKids-Caribbean Initiative (SCI).

In 2013, the SickKids-Caribbean Initiative (SCI) was formalised among The Hospital for Sick Children in Toronto, Canada, the University of the West Indies, and Ministries of Health in six Caribbean countries (Barbados, The Bahamas, Jamaica, St. Lucia, St. Vincent and the Grenadines, and Trinidad and Tobago). The aim was to improve the outcomes and quality of life of children (<18 years) with cancer and blood disorders in the partner countries. Core activities included filling a human resource gap by training paediatric haematologists/oncologists and specialised registered nurses; improving capacity to diagnose and treat diverse haematology/oncology cases; developing and maintaining paediatric oncology databases; creating ongoing advocacy activities with international agencies, decision makers, and civil society; and establishing an integrated administration, management, and funding structure. We describe core program components, successes, and challenges to inform others seeking to improve health service delivery in a multidisciplinary and complex partnership.

Oral iron supplementation ameliorated alterations in iron uptake and utilization in copper-toxic female Wistar rats.

OBJECTIVE: Women are more susceptible to both iron deficiency and copper toxicity due to monthly flow and estrogen action, respectively. Oral iron is beneficial for menstruating women and enhances erythropoiesis, but both deficiency and excess of copper impact iron absorption and mobilization. The aim of this study was to investigate the possibility of mitigating copper toxicity in female Wistar rats while supplementing with iron. METHODS: 20 female rats (160-180g) were grouped into four: Groups 1 (Control) received 0.3mls normal saline, 2- copper-toxic (100m mg/kg Copper sulphate), 3- Copper-toxic+Iron (100 mg/kg Copper sulphate + 1 mg/kg Ferrous sulphate) and 4- Iron (1 mg/kg Ferrous sulphate). All treatment was administered orally for 5 weeks. Blood was collected retro-orbitally after light anesthesia into EDTA and plain bottles for hematological, serum copper, iron, ferritin and total iron binding capacity (TIBC) analysis. Liver was excised for copper and iron levels while bone marrow was harvested for myeloid/erythroid ratio. The data were analyzed by one-Way ANOVA and statistical significance was considered at p<0.05. RESULTS: Iron supplementation significantly increased packed cell volume, hemoglobin concentration, red blood cell count and myeloid/erythroid ratio, compared to the copper-toxic group. Serum iron and TIBC were significantly increased while liver copper and iron levels reduced significantly in iron supplemented group compared to the copper-toxic group. CONCLUSIONS: Oral iron supplementation mitigated alterations in iron absorption and mobilization following copper toxicity.

Nutritional feed additives reduce the adverse effects of transport stress in the immune system of Tambaqui (Colossoma macropomum).

Here we show that selected nutritional feed additives reduce the adverse effects of transport stress on the immune system and hematology of tambaqui. We formulated a control diet to contain normal dietary levels of vitamin E (21.6 mg/ kg diet) and C (143 mg/kg), then we added supra levels of these vitamins (vit E - 264 mg/kg and vit C - 1000 mg/kg) to a second diet. Finally, a third diet was produced to contain similar levels of vitamins from diet 2 with 0.1% beta-glucan supplementation. Four hundred thirty-two tambaquis (20.91 g ± 0.27 g) were randomly assigned to 12 aquaria and fed the diets for 15 days; then, all fish were transported for five h and then returned to the aquaria. Blood samples were collected before and after the transport and at the end of the trial (60 days). Transportation significantly increased blood glucose that returned to baseline levels at the end of the trial. However, cortisol seemed to be unresponsive to the stress. Surprisingly, the stress significantly increased the immunoglobulin level after transport. Additionally, the transport markedly reduced the red blood cell count and leukocyte and lymphocytes counts while increasing the control group's neutrophil number. These effects lasted until the end of the trial in the control group. Supra levels of the vitamins and glucan supplementation prevented the decrease in red blood cell and leukocyte count after the stress. Additionally, beta-glucan supplementation induced lower cortisol levels in all the sampling points. However, the effect on the immune parameters was limited, increasing only the lysozyme activity and serum protein levels in the beta-glucan supplemented group and the group fed only the supra levels of vitamins, respectively. In sum, our results indicated that transport for five h induced a limited effect on stress biomarkers. The use of supra levels of antioxidant vitamins alone or in combination with beta-glucan could restore or prevent the adverse effects of stress on hematology and the immune system.

Non-diseased aortic mural thrombus presenting with acute limb ischaemia.

We present a case of a thoracic aortic mural thrombus (AMT) in a non-atherosclerotic and non-aneurysmal aorta that presented with acute limb ischaemia. AMT in a non-diseased aorta without an underlying hypercoagulable disorder is rare. The AMT in our patient was managed with anticoagulation, which resolved on a 5-month follow-up CT scan. This provided us an opportunity to discuss the successful medical management of an AMT, to review the literature on the management of AMT and to add to the literature on a rare presentation of an AMT.

AnemiaAR: a serious game to support teaching of haematology.

Serious games can be suitable tools for educational support in different areas of knowledge, such as Medicine. These applications, combined with technologies like mixed and augmented reality, provide a differentiated user experience that can keep or improve the interest and motivation of students and teachers during the teaching and learning process. In this context, this study aimed to present the development of AnemiaAR, a mixed reality serious game to support the teaching of haematology, helpful for students and professors in the visualisation and presentation of anaemia concepts. Fourteen medical students from the University of Passo Fundo participated in a pilot study to evaluate the application, considering a sociodemographic questionnaire, a questionnaire based on the Technology Acceptance Model, and two modules of the Game Experience Questionnaire. The preliminary results were satisfactory, showing good acceptance and positive experience of the game, besides improvements. The study also pointed out differences in the game evaluation among participants, considering the prior experience in games, the previously attended haematology subject, and the time spent performing the game tasks.

Myelopathy associated with intrathecal methotrexate.

A 21-year-old man developed progressive and bilateral lower limb numbness, gait impairment and urinary incontinence over 10 days. He had received intrathecal methotrexate 20 days previously for acute lymphoblastic B-cell leukaemia, following 7 months of systemic chemotherapy. MR scan of the spinal cord showed bilateral symmetric and extensive T2/fluid attenuated inversion recovery (FLAIR) increased signal involving the dorsal columns in the thoracic cord. His serum folate concentration was at the lower end of the normal range. We stopped the intrathecal chemotherapy and gave folate; after a few days, he progressively improved. Myelopathy is an important adverse effect of intrathecal methotrexate, which may cause clinical and imaging features resembling subacute combined degeneration of the spinal cord. CNS infiltration must be excluded, intrathecal chemotherapy stopped and deficiency of folate or vitamin B12 treated as appropriate.

Gemtuzumab-ozogamicin and blinatumomab as treatment for refractory mixed-phenotype blast crisis in chronic myeloid leukaemia.

In the tyrosine kinase inhibitor era, the blast phase of chronic myeloid leukaemia (BP-CML) renders an uncommon presentation and has a poor prognosis with an estimated overall survival below 20%. Mixed-phenotype blast phase is even more infrequent, presenting in 3.3% of these patients. Blast phase manifests along haematological sarcomas, with extramedullary activity in lymph nodes, skin and bone. We report the case of a patient with an ovarian sarcoma as an extramedullary presentation of mixed-phenotype BP-CML refractory to conventional treatment which responded to immunotherapy against CD33 and CD19.

Haematological changes in rabbits (Oryctolagus cuniculus f. domesticus) in the course of pregnancy.

The analysis of haematological parameters is an important element of the assessment of the physiological condition of animals. Haematological parameters may change both under the influence of various external factors, and in the course of normal pregnancy, which has been found in various species of mammals, including rabbits. Our study showed statistically significant (p<0.05) changes in basic haematological parameters: RBC (decrease; 5.87±0.48 at day 15 vs. 5.42±0.32 T/L at day 26), MCH (increase; 1.35±0.04 before matching vs. 1.41±0.03 fmol at day 26), RDW (decrease; 15.77±1.80 at day 15 vs. 14.27±1.57% at day 26) MPV (increase; 5.17±0.31 at day 15 vs. 5.92±0.70 fL at day 26), WBC (decrease; 8.60±2.57 at day 15 vs. 4.94±0.88 G/L at day 26) and PLT (decrease; 398.17±91.67 before matching vs. 271.67±61.72 G/L at day 26) in Termond White rabbits and RBC (decrease; 6.18±0.68 before matching vs. 5.68±0.54 T/L at day 26), Hb (decrease; 8.00±0.90 before matching vs. 7.32±0.71 mmol/L at day 26), MCH (decrease; 1.32±0.05 at day 15 vs. 1.29±0.04 fmol at day 26) and WBC (decrease; 9.62±1.81 before matching vs. 5.85±2.23 G/L at day 26 as well as 9.58±2.35 at day 15 vs. 5.85±2.23 G/L at day 26) in Popielno White rabbits. Moreover, in the Popielno White rabbits we recorded a significant (p<0.05) decrease in the percentage of irregular erythrocytes at the end of pregnancy (11.00±10.02 at day 15 vs. 3.00±4.94 at day 26). The changes appear to be physiological but should be considered in studies using rabbits as model organisms.

Primary diffuse large B cell lymphoma of the optic chiasm in an immunocompetent patient.

Primary lymphoma of the visual pathway is rare, especially at the chiasm. Very few cases have been reported. The lesion is frequently confused with an optic-hypothalamic glioma. A 55-year-old man was found disoriented at his home by a friend and evaluated with a brain MRI which demonstrated an expansile mass located at the optic chiasm and hypothalamus level. The principal differential was a high-grade hypothalamic glioma due to the contrast enhancement. A biopsy of the chiasmal lesion was performed. Histological diagnosis of the lesion was compatible with a diffuse large B cell lymphoma. He was started on methotrexate and rituximab; however, his clinical course kept deteriorating, and he died 64 days after his presentation. All prior cases of primary lymphoma of the chiasm are reviewed.

Effects of sodium butyrate and Lippia origanoides essential oil blend on growth, intestinal microbiota, histology, and haemato-immunological response of Nile tilapia.

This study aimed to verify the effects of dietary supplementation with sodium butyrate and Lippia origanoides, combined and isolated, on the health and zootechnical performance of Nile tilapia juveniles Oreochromis niloticus. A total of 120 fish (5.38 ± 0.65 g) were randomly distributed in 12 experimental units and fed different experimental diets for 30 days, namely: commercial diet without supplementation (Unsupplemented); commercial diet supplemented with 0.5% sodium butyrate (Butyrate); commercial diet supplemented with 0.125% L. origanoides (Lippia) and commercial diet supplemented with a mixture of 0.5% sodium butyrate and 0.125% L. origanoides (Butyrate + Lippia). After preparing the experimental diets there was an increase in the pH of diet Butyrate when compared to the other diets. After 30 days the fish supplemented with Butyrate + Lippia showed reduction significate in the mean corpuscular haemoglobin, concentration of total heterotrophic bacteria in the intestine, and lymphocyte infiltrates in the liver. Besides that, the supplementation with Butyrate + Lippia promoted an increased number of intestinal villi compared to the fish Unsupplemented ones. Additionally, fish fed a diet containing only Lippia presented an increase in the villus perimeter in the posterior region of the gut and in the red blood cell number. Animals supplemented only with sodium butyrate demonstrated increased lactic acid bacterium in the gut and macrosteatosis in the liver, besides decreased melanomacrophages in the spleen. The use of sodium butyrate associated with essential oil had positive effects on the intestinal microbiota, intestinal structure, liver, and spleen integrity, suggesting a greater efficiency of the compounds when used together in the nutrition of Nile tilapia juveniles.

The paediatric cancer clinical research landscape in Spain: a 13-year multicentre experience of the new agents group of the Spanish Society of Paediatric Haematology and Oncology (SEHOP).

PURPOSE: Early phase trials are crucial in developing innovative effective agents for childhood malignancies. We report the activity in early phase paediatric oncology trials in Spain from its beginning to the present time and incorporate longitudinal data to evaluate the trends in trial characteristics and recruitment rates. METHODS: Members of SEHOP were contacted to obtain information about the open trials at their institutions. The study period was split into two equal periods for analysis: 2007-2013 and 2014-2020. RESULTS: Eighty-one trials and two molecular platforms have been initiated. The number of trials has increased over the time of the study for all tumour types, with a predominance of trials available for solid tumours (66%). The number of trials addressed to tumours harbouring specific molecular alterations has doubled during the second period. The proportion of industry-sponsored compared to academic trials has increased over the same years. A total of 565 children and adolescents were included, with an increasing trend over the study period. For international trials, the median time between the first country study approval and the Spanish competent authority approval was 2 months (IQR 0-6.5). Fourteen out of 81 trials were sponsored by Spanish academic institutions. CONCLUSIONS: The number of available trials, and the number of participating patients, has increased in Spain from 2007. Studies focused on molecular-specific targets are now being implemented. Barriers to accessing new drugs for all ranges of age and cancer diseases remain. Additionally, opportunities to improve academic research are still required in Spain.

Effect of hydro-methanol stem extract of Anacardium occidentale on haematology and serum biochemistry in cockerels / Efecto del extracto de hidro-metanol del tallo de Anacardium occidentale sobre la hematología y la bioquímica del suero en gallos jóvenes

Abstract This study aims to investigate the effects of orally administered graded doses of hydro-methanol stem extract from Anacardium occidentale (MSEAO) on the haematology and serum biochemistry of chickens. Forty, 8-weeks old cockerel chickens were randomly assigned into four groups (groups 1, 2, 3 and 4) of ten birds each. Groups 1, 2 and 3 received 3000, 1500 and 500 mg/kg body weight of MSEAO, respectively, while chickens in control group (group 4) were given drinking water placebo. Blood samples were collected from all chickens on day 0- and 48-hours post-treatment. Haematology and serum biochemistry were evaluated following standard procedures. The results showed that most of the haematological parameters in the treated groups did not differ significantly as compared to the control group. The serum biochemistry results showed that the serum alanine aminotransferase (ALT) activity ingroups 1 and 2 were significantly (P < 0.05) lower than that ingroups 3 and 4. Serum uric acid levels ingroups 1 and 2 chickens were significantly (P < 0.05) lower than that in the control group, while the creatinine levels of chickens in the treated groups were significantly (P < 0.05) lower than that of chickens in the control group. It was concluded that MSEAO, as used in the study, led to significant changes in heterophil counts, serum ALT and ALP activities, uric acid, creatinine, and calcium levels.

Resumen El objetivo de este estudio es investigar los efectos de dosis graduales de extracto de hidro-metanol del tallo de Anacardium occidentale (MSEAO) administradas por vía oral sobre la hematología y bioquímica del suero de polluelos. Cuarenta pollos de 8 semanas de edad fueron asignados al azar en cuatro grupos (1, 2, 3 y 4) de diez pollos cada grupo. Los grupos 1, 2 y 3 recibieron 3000, 1500 y 500 mg/kg de peso corporal de MSEAO, respectivamente, mientras que a los pollos del grupo de control [grupo 4] se les dio agua de beber como placebo. Se tomaron muestras de sangre de todos los pollos a las 0 y 48 horas después del tratamiento. Se evaluó la hematología y la bioquímica del suero siguiendo procedimientos estándares. Los resultados mostraron que la mayoría de parámetros hematológicos en los grupos tratados no difirieron significativamente con respecto al grupo de control. Los resultados de la bioquímica del suero mostraron que la actividad de la alanina aminotransferasa en el suero (ALT) en los grupos 1 y 2 fue significativamente inferior (P < 0.05) a la de los grupos 3 y 4. Los niveles de ácido úrico en el suero en los pollos de los grupos 1 y 2 fueron significativamente inferiores (P < 0.05) a los del grupo de control, mientras que los niveles de creatinina de los pollos en los grupos de tratamiento fueron significativamente inferiores (P< 0.05) a los de los pollos del grupo de control. Se concluyó que el MSEAO, como se usó en este estudio, produjo cambios significativos en los conteos de heterófilos, en las actividades de ALT y ALP del suero y en los niveles de ácido úrico, creatinina y calcio.

Lead exposure in dogs fed game meat and offal from culled invasive species in El Palmar National Park, Argentina.

This is the first field study to evaluate lead exposure in dogs fed game meat and offal and, to our knowledge, the first study exploring associations between game consumption and dog health status. We quantified lead concentrations in blood and hair and haematological parameters of 31 dogs fed game meat and offal from wild boar (Sus scrofa) and axis deer (Axis axis) culled with lead ammunition in El Palmar National Park, Argentina. Despite variable weekly frequency in game consumption, dogs had detectable blood and hair lead levels, demonstrating recent and chronic exposure. Lead geometric mean and SD were 18.91 ± 346.85 µg/dL w.w. in blood (range = 0.53-216.58), and 0.721 ± 6.444 µg/gr d.w. in hair (range = 0.007-34.800). Hair lead levels were relatively low in most samples, except for the oldest dog which had an atypically high value concurrent with anaemia, a common outcome of chronic lead exposure. Dog's owner was significantly predictive of both blood and hair lead levels, which reflects the same feeding patterns for all dogs owned by the same person. Body condition was associated with hair lead, with dogs in good condition presenting higher lead levels. This could be related to greater game consumption by those dogs, resulting in higher lead ingestion. Dogs fed game meat and offal at very low or low frequency (≤4 times per week) showed higher blood lead levels, suggesting there might not be a risk-free frequency for game provision to dogs. Considering the risks of dietary lead exposure, avoiding feeding dogs lead-killed game and replacing lead ammunition with non-toxic alternatives are recommended. This would allow using hunted game as a valuable food resource without unnecessary risk for the health of consumers and the environment.

Challenges in early phase clinical trials for childhood cancer during the COVID-19 pandemic: a report from the new agents group of the Spanish Society of Paediatric Haematology and Oncology (SEHOP).

PURPOSE: The COVID-19 pandemic has forced healthcare stakeholders towards challenging decisions. We analyse the impact of the pandemic on the conduct of phase I-II trials for paediatric cancer during the first month of state of alarm in Spain. METHODS: A questionnaire was sent to all five ITCC-accredited Spanish Paediatric Oncology Early Phase Clinical Trial Units, including questions about impact on staff activities, recruitment, patient care, supply of investigational products, and legal aspects. RESULTS: All units suffered personnel shortages and difficulties in enrolling patients, treatment continuity, or performing trial assessments. Monitoring activity was frequently postponed (73%), and 49% of on-going trials interrupted recruitment. Only two patients could be recruited during this period (75% reduction in the expected rate). CONCLUSIONS: The COVID-19 crisis has significantly impacted clinical research practice and access to innovation for children with cancer. Structural and functional changes are under way to better cope with the expected future restrictions.