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Informed consent is one of the key elements to protect the rights and welfare of the patients or research subjects. With the development of electronic information technology, the diversity and convenience brought by the electronization makes the electronic informed consent (E-Consent) come into being. European and American countries have begun to apply E-Consent in the field of clinical trials, established a relatively perfect E-Consent platform and software system, and initially formed the guiding principles and recommendations of E-Consent. However, the implementation of E-Consent is still less in China, and there is no targeted legal basis and guidelines for ethical review. Therefore, this paper explored the implementation potential of E-Consent domestically by analyzing the application scenarios, advantages and disadvantages, and feasibility of E-Consent, and tried to establish the practical ethic review points of E-Consent based on the basic principles of ethical principles, to ensure that clinical trials have an appropriate E-Consent process.
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Research-oriented hospitals are the currently development direction of large hospitals, and their research ethics management has played an important role in China’s scientific and technological innovation and clinical research development through years of practice. However, at present, China’s overall scientific and technology ethics governance framework system is still incomplete, governance authority is insufficient, ethics committee members lack ethical professional technical training, and the awareness and understanding of science and technology ethics among medical staff still need to be improved, which indicates that the level of technology ethics governance in research-oriented hospitals needs to be improved. It is suggested to improve from the aspects of regulatory system, governance responsibilities, training of ethical practitioners, supervision and punishment measures, and ethical education of scientific and technological research talents, so as to better protect subjects and promote the construction of scientific and technological ethics in the research-oriented hospitals.
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Extended clinical trials are medical treatment activity based on the humanitarianism to provide new medical products during the clinical trials for specific patients who have no other effective medical means to prolong life or alleviate pain. Extensive clinical trials have both medical and scientific attributes, which are significantly different from registered clinical trials and require special ethical attention. At present, the extended clinical trials in China are still in the initial stage, laws, regulations and supporting management methods are not perfect, and there is a lack of experience in ethical governance of such special clinical trials. This paper took the expanded clinical trial of medical devices as an example, referred to the current laws and regulations at home and abroad, analyzed their characteristics, and put forward some suggestions on the ethical governance of the whole process of the expanded clinical trials of medical devices in China,including special concerns in the application and acceptance, the first review approval strategy and the key points in continuing review.
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Objective:To assess the value of 18F-FDG PET/CT imaging and relevant factors in the interim therapeutic and prognostic evaluation of primary gastrointestinal lymphoma (PGIL) patients. Methods:From January 2008 to January 2018, 41 patients with B-cell PGIL (24 males, 17 females; age: 26-84 years) confirmed by pathology in Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine were retrospectively included. 18F-FDG PET/CT was performed before chemotherapy and radiotherapy and after 3-4 courses of chemotherapy. There were 17 cases of mucosa-associated lymphoid tissue (MALT) lymphoma and 24 cases of diffuse large B-cell lymphoma (DLBCL). Mann-Whitney U test was used to compare the differences of metabolic parameters (SUV max, metabolic tumor volume (MTV), total lesion glycolysis (TLG)) before treatment between MALT lymphoma and DLBCL patients. ROC curve analysis was used to analyze the predictive abilities of different parameters for progression-free survival (PFS), and Cox regression analysis was used to analyze the influencing factors for PFS. Results:The median follow-up time of 41 patients was 25 (6-84) months, with the 3-year PFS rate of 55.9% and the overall survival (OS) rate of 80.2%. The baseline SUV max (23.2±11.9), MTV (260.7(66.2, 740.7) cm 3) and TLG (1 902.9(592.2, 8 418.1) g) in DLBCL were significantly higher than those in MALT lymphoma (7.9(6.2, 9.8), 45.9(28.4, 104.2) cm 3, 121.1(72.8, 295.6) g; z values: -4.02, -3.10, -3.92, all P<0.05). ΔSUV max in DLBCL patients (AUC=0.80, P=0.012), ΔSUV max% (AUC=0.89, P=0.007; AUC=0.80, P=0.012), ΔMTV%(AUC=0.91, P=0.005; AUC=0.77, P=0.026) and ΔTLG% (AUC=0.87, P=0.011; AUC=0.77, P=0.026) in MALT lymphoma and DLBCL patients before and after treatment were predictive factors of PFS. Multivariate analysis showed that ΔSUV max% was an independent factor for PFS of MALT lymphoma (hazard ratio ( HR)=17.192, 95% CI: 2.035-145.245, P=0.009), while ΔMTV% and ΔTLG% were factors for PFS of DLBCL (both HR=7.556, 95% CI: 1.968-29.016, P=0.003). Conclusions:There are significant differences in metabolic parameters between MALT lymphoma and DLBCL before treatment. Interim PET/CT is effective for the prediction of prognosis of MALT lymphoma and DLBCL.
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Objective:To assess the predictive value of 18F-fluorodeoxyglucose (FDG) PET/CT imaging and relevant factors in the prognosis of patients with classic Hodgkin lymphoma (cHL) before or after autologous stem cell transplantation (ASCT). Methods:From January 2008 to June 2017, 55 cHL patients (28 males, 27 females; age: (28.8±9.6) years) confirmed by pathology in Shanghai General Hospital were retrospectively included. 18F-FDG PET/CT imaging was performed before ASCT in 43 cases and after ASCT in 34 cases (22 patients underwent the imaging both before and after ASCT). Patients were divided into positive group (≥4) and negative group (<4) according to 18F-FDG PET/CT imaging results using Deauville 5-point scale. The predictive value of relevant factors in the prognosis was evaluated with progression-free survival (PFS) and overall survival (OS) using Kaplan-Meier survival analysis and log-rank test. Hazard ratio ( HR) was calculated by Cox regression model. Results:Of 55 cHL patients, 29 (53%) had a progression of disease after a median follow-up of 8 months, and 11 (20%) patients died after a median follow-up of 29.5 months, with the 3-year PFS rate of 46.4% and OS rate of 84.5%. Significant differences of PFS rate were found between patients with or without B symptoms, between patients with or without large mediastinal mass, between patients with international prognostic score (IPS) of 0-2 and those with IPS of 3-7, among patients with different effect of salvage chemotherapy (complete remission (CR), partial remission (PR) + stable disease (SD), progressive disease (PD)), and between patients with negative or positive PET/CT imaging results before or after ASCT ( χ2 values: 5.52-20.01, HR: 2.21(95% CI: 1.56-3.12)-5.51(95% CI: 1.86-16.33), all P<0.05). B symptoms and large mediastinal mass were also prognostic factors for OS rate ( HR: 5.28(95% CI: 1.14-24.51) and 4.27(95% CI: 1.24-14.79), both P<0.05). The combination of 18F-FDG PET/CT imaging before and after ASCT was statistically significant for predicting PFS ( χ2=11.28, P<0.01). Multivariate survival analysis showed that the risk of progression in patients with positive PET/CT results after ASCT was significantly higher than those with negative results ( HR=6.20, P<0.01), and the risk of death in patients with B symptoms was significantly higher than those without B symptoms ( HR=5.28, P<0.05). Conclusion:18F-FDG PET/CT imaging results after ASCT have important values for predicting PFS in cHL patients after ASCT, and B symptoms can be used as an important prognostic indicator of OS after ASCT.
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Objective To assess the value of 18F-fluorodeoxyglucose (FDG) PET/CT in the staging,interim therapeutic and prognostic evaluation of mucosa-associated lymphoid tissue (MALT) lymphoma.Methods Thirty-six MALT lymphoma patients (20 males,16 females;average age:61.7 years) confirmed by pathology from January 2008 to January 2018 were retrospectively analyzed.18F-FDG PET/CT were performed before chemotherapy and radiotherapy for staging.The detective sensitivity was evaluated.The staging results of gastric MALT lymphoma and extragastric MALT lymphoma by PET/CT were compared with Fisher exact probability method.PET/CT was performed in 17 of 36 patients after 4 courses of chemotherapy,and 17 patients were divided into positive group (≥≥4) and negative group (＜4) according to scores of Deauville 5-point scale.The progression-free survival (PFS) was evaluated using Kaplan-Meier survival analysis.Results FDG-positive lesions were found in 31 of 36 patients with the sensitivity of 86.1％ (31/36).The results of PET/CT were negative in stage Ⅰ patients.In stage]Ⅱ-Ⅳ patients,the results of 18F-FDG PET/CT combined with bone marrow biopsy were in accordance with the results of clinical staging.The accuracy of PET/CT in staging of gastric MALT lymphoma patients was 9/17,which was significantly lower than that of extragastric MALT lymphoma patients (17/19;P=0.025).The PFS of negative group evaluated by interim PET/CT was longer than that of positive group (x2 =4.16,P＜0.05).The 2-year PFS rates of the 2 groups were (85.7± 13.2)％ and (27.8 ±21.3)％,respectively.The PFS of patients with low expression of Ki-67 was significantly longer than that of patients with high Ki-67 expression (x2=4.22,P＜0.05).Conclusions In stage]Ⅱ-Ⅳ MALT patients,18F-FDG PET/CT combined with bone marrow biopsy can improve the staging accuracy.The staging accuracy of PET/CT in extragastric MALT lymphoma is significantly higher than that of gastric MALT lymphoma.PET/CT and Ki-67 can provide effective information on the prognostic evaluation for patients with MALT lymphoma.
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Glioma is the most common malignant brain tumor with high malignancy and lethality.The specific potential radiolabeled nanoparticles have been applied in the glioma research for non-invasive,dynamic,real-time and quantitative evaluation.Furthermore,radiolabeled nanoparticles have shown great potential in targeted therapy of glioma.The up-to-date application of radiolabeled nanoparticles in SPECT imaging,PET imaging,multimodality imaging and theranostics in glioma are reviewed in this article.