ICH GCP requires that all information of clinical trial should be recorded, processed, and stored in a way that allows the accurate reporting, interpretation and verification. A trial master file (TMF) contains all paper or electronic records/documentations related to a clinical trial. As a tool of the retrospective analysis, the TMF profile should be able to reproduce the full procedure of the trial completely. As a part of TMF profiles, both the accuracy and completeness of clinical data management documentation are important in data integrity. It is helpful to learn the workflow of clinical data management in different stage of a clinical trial, to understand which documents are essential, and why the documentation of clinical data management is important for data integrity. This paper elaborates how to perform the good documentation practice of clinical data management, and suggests that both the precise and efficient document management and regular quality control may ensure the high quality of clinical data documentation management on the basis of an intensive awareness of the overall process of clinical data management.
Clinical Trials as Topic ; Data Curation ; standards ; Information Storage and Retrieval ; methods ; standards

Recently, it is reported that regulatory T cells (Tregs) can be reprogrammed into a novel population [interleu?kin (IL)-17+Foxp3+T cells] phenotypically and functionally resembling Th17 cells under complicated cytokine circumstanc?es. IL-17+Foxp3+T cells are characterized by production of IL-17 and expression of retinoic acid receptor related orphan re?ceptor (ROR)γt, demonstrating dual functions in immune response and providing novel insight into the interconnection be?tween Tregs and Th17 cells. In this review, we lay emphasis on the phenotype features, origination, differentiation and the pleiotropic functions of IL-17+Foxp3+T cells. Furthermore, we summarized the functions of IL-17+Foxp3+T cells in inflam?matory disease and tumor microenvironment.

Objective To study on the relationship of PTEN with clinicopathological parameters and prognosis of esophageal squamous cell carcinoma patients.Methods The expression of PTEN was detected in 62 cases of esophageal squamous cell carcinomas by immunohistochemistry.Results(1)PTEN expres- sion is negatively correlated with the depth of invasion,lymph node metastasis,distant metastasis,pTNM stage and degree of differentiation.(2)The difference of survival is significant between high and low expres- sion groups.Conclusion PTEN is correlated negatively with the clinicopathological parameters reflecting the malignant biological behavior,and is one of the significant prognostic predictors by univariate analysis.

Objective: This study aims to investigate the correlation between the expression of FoxP3, TGF-β1, and epitheli-al-mesenchymal transition (EMT) in breast cancer and to determine the clinical significance of FoxP3. Methods: The expression of FoxP3, TGF-β1, E-Cadherin, N-Cadherin, Vimentin, and Fibronectin protein were detected in the cancer cells of 74 cases with breast carcinoma via immunohistochemistry. The correlation of FoxP3 protein with clinico-pathologic features of breast carcinoma and the re-lationships among the expressions of FoxP3, TGF-β1, and epithelial-mesenchymal transition (EMT) were analyzed. Results:The ex-pression rates of FoxP3, TGF-β1, and EMT are 36.5%(27/74), 39.2%(29/74), and 40.5%(30/74), respectively. The FoxP3 protein ex-pression in breast cancer is correlated with lymph node metastasis (P<0.05) but not with other clinico-pathological features (P>0.05). The expression of FoxP3 is also correlated with the expression of TGF-β1. Furthermore, TGF-β1 can induce EMT (P<0.05). Conclu-sion:The expression of FoxP3 is correlated with lymph node metastasis and EMT in breast cancer. Therefore, FoxP3 may be a marker for predicting metastasis.

Objective To investigate the influence of CO2 pneumoperitoneum on the adhesive and invasive ability of gastric cancer cells based on the expression of adhesive and invasive molecules. Methods With an artificial CO2 pneumoperitoneum model in vitro, human gastric cancer cells MKN-45, SGC-7901 and MKN-28 were exposed to 3 different CO2 gradients: 9 mm Hg, 15 mm Hg and control group (0 mm Hg). The expression of E-cadherin, ICAM-1, MMP-2 and VEGF-A were measured at 2 and 4 hours exposure by using RT-PCR, CytoMatrixTM kit and ECMatrixTM kit. The pretreated gastric cancer cells were injected into abdominal cavity of nude mice(2×106 cells per mouse). Five mice in each group were sacrificed 4 weeks later to record the number of tumor nodules in abdominal cavity. The remaining mice were kept for observation of survival time. Results The expression of E-cadherin (MKN-45: from 2.26 to 2.19, SGC-7901 :from 2.16 to 2.09、MKN-28 :from 2.06 to 1.99), ICAM-1 (MKN-45 : from 2.20 to 2.28、SGC-7901: from 2.10 to 2.18、MKN-28: from 2.00 to 2.08), MMP-2 (MKN-45:from 2.05 to 2.13、SGC-7901: from 1.95 to 2.03、MKN-28: from 1.85 to 1.93) and VEGF-A(MKN-45 : from 2.10 to 2.16、SGC-7901 :from 2.00 to 2.06、MKN-28: from 1.90 to 1.96) didn't change significantly with increasing pressure and time (P>0.05). The expression of adhesive and invasive molecules didn't change significantly between the experimental groups and the control group. There was no statistical significance of tumor metastasis in abdominal cavity of nude mice(MKN-45:from 22 to 23、SGC-7901 :from 20 to 22、MKN-28:from 21 to 22) and survival time(MKN-45 :from 23 to 21、SGC-7901 :from 22 to 21、MKN-28 :from 22 to 21) among all the groups. Conclusion Under low pressure and short time of CO2 exposure, the adhesive and invasive capacity of gastric cancer cells did not change significantly hence did not increase the possibility of neoplasm metastasis.

Actins ; metabolism ; Adenocarcinoma ; pathology ; Adult ; Diagnosis, Differential ; Endometriosis ; pathology ; Epithelium ; pathology ; Female ; Gastrointestinal Stromal Tumors ; pathology ; Hamartoma ; metabolism ; pathology ; Humans ; Muscle, Smooth ; pathology ; Stomach Diseases ; metabolism ; pathology

Castleman Disease ; genetics ; pathology ; surgery ; Diagnosis, Differential ; Female ; Gene Rearrangement, B-Lymphocyte, Heavy Chain ; Humans ; Hyperplasia ; Lung ; pathology ; surgery ; Lung Diseases ; genetics ; pathology ; surgery ; Lymph Nodes ; pathology ; Middle Aged

Child ; Female ; Humans ; Sarcoma, Myeloid ; Spine ; pathology

Animals ; Disease Models, Animal ; Heart Rate ; Hypertension ; physiopathology ; Rats ; Rats, Wistar

There is no radical cure for essential thrombocythemia currently. Professor SUN Xue-mei has extensive clinical experience in treating it by combined therapy of Chinese and Western medicine. In this paper, authors tried to summarize her experience from guiding ideology and therapeutic points. Authors insisted on the direction of integrative medicine on the basis of syndrome differentiation, paying attention to psychological counseling,and applied individual treatment in clinics.
Acupuncture Therapy ; Female ; Humans ; Integrative Medicine ; Medicine, Chinese Traditional