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Clinical Database and Biobank of Patients With Gynecologic Neoplasms

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ClinicalTrials.gov Identifier: NCT01267851
Recruitment Status : Recruiting
First Posted : December 29, 2010
Last Update Posted : July 19, 2019
Sponsor:
Collaborators:
Zhejiang University
Hunan Province Tumor Hospital
Guangxi Medical University
First Affiliated Hospital Xi'an Jiaotong University
West China Second University Hospital
Obstetrics & Gynecology Hospital of Fudan University
Shanghai First Maternity and Infant Hospital
Peking University People's Hospital
The Central Hospital of Wuhan
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology

Tracking Information
First Submitted Date December 28, 2010
First Posted Date December 29, 2010
Last Update Posted Date July 19, 2019
Actual Study Start Date January 1, 2010
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Database and Biobank of Patients With Gynecologic Neoplasms
Official Title A Large Multicentre Clinical Database and Biobank of Patients With Gynecologic Neoplasms
Brief Summary The database and biobank establishment started in 1997 in our institute. However, the sample size was too small with respect to our clinical and fundamental scientific research's requirement. Thus the Chinese gynecological oncology study (GOS) group was established to create a large multicentre database and biobank of patients with gynecologic diseases.
Detailed Description

The database contains clinical and epidemiologic information about patients with gynecologic neoplasms, such as cervical carcinoma, ovarian carcinoma, etc. With the data gathered from this database, the investigators could further demonstrate the etiology, risk factor, clinical treatment, and other aspects of the complicated gynecologic diseases. The cervical cancer database v1.10 including more than 10,000 cases and more than 200 variables has been established.

The biobank collects blood, fluids, tissue samples, and related clinical data from consenting patients with gynecologic neoplasms, such as cervical cancer, ovarian cancer, endometrial cancer, choriocarcinoma, uterine myoma, endometriosis. Besides, blood samples of population-based healthy people with informed consent are also collected.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population gynecologic diseases, such as cervical cancer, ovarian cancer, endometrial cancer, choriocarcinoma, uterine myoma, endometriosis, as well as part of population-based healthy women
Condition
  • Cervical Cancer
  • Ovarian Cancer
  • Endometrial Cancer
  • Choriocarcinoma
  • Uterine Myoma
  • Endometriosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Hu T, Li S, Chen Y, Shen J, Li X, Huang K, Yang R, Wu L, Chen Z, Jia Y, Wang S, Cheng X, Han X, Lin Z, Xing H, Qu P, Cai H, Song X, Tian X, Xu H, Xu J, Zhang Q, Xi L, Deng D, Wang H, Wang S, Lv W, Wang C, Xie X, Ma D. Matched-case comparison of neoadjuvant chemotherapy in patients with FIGO stage IB1-IIB cervical cancer to establish selection criteria. Eur J Cancer. 2012 Oct;48(15):2353-60. doi: 10.1016/j.ejca.2012.03.015. Epub 2012 Apr 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July¬†16,¬†2019)
1600000
Original Enrollment Not Provided
Estimated Study Completion Date December 30, 2020
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients with informed consent;
  • patients with gynecologic diseases;
  • patients with intact clinical and pathological information

Exclusion Criteria:

  • not included in the inclusion criteria
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Ma Ding, M.D. 86-27-8362681 dma@tjh.tjmu.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01267851
Other Study ID Numbers GM2010-06-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ding Ma, Huazhong University of Science and Technology
Study Sponsor Huazhong University of Science and Technology
Collaborators
  • Zhejiang University
  • Hunan Province Tumor Hospital
  • Guangxi Medical University
  • First Affiliated Hospital Xi'an Jiaotong University
  • West China Second University Hospital
  • Obstetrics & Gynecology Hospital of Fudan University
  • Shanghai First Maternity and Infant Hospital
  • Peking University People's Hospital
  • The Central Hospital of Wuhan
Investigators Not Provided
PRS Account Huazhong University of Science and Technology
Verification Date July 2019