Cervical CancerNCT01267851
Clinical Database and Biobank of Patients With Gynecologic Neoplasms
An observational study of Cervical Cancer and Ovarian Cancer, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Ovarian Cancer, Endometrial Cancer
- How many people
- 1,600,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- patients with informed consent;
- patients with gynecologic diseases;
- patients with intact clinical and pathological information
Who cannot join
- not included in the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital of HUST
Wuhan, Hubei
Ma Ding, M.D., 86-27-8362681, dma@tjh.tjmu.edu.cn
About this study
Official title: A Large Multicentre Clinical Database and Biobank of Patients With Gynecologic Neoplasms
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.
Read the 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.
- Conditions
- Cervical Cancer, Ovarian Cancer, Endometrial Cancer, Choriocarcinoma, Uterine Myoma, Endometriosis
- Keywords
- gynecologic disease
- Medical subject headings
- Uterine Cervical Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Choriocarcinoma, Myofibroma, Endometriosis, Genital Diseases, Female
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study start1 Jan 2010
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,600,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- 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, Wuhan Central Hospital
- Responsible party
- Principal investigator, Ding Ma, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267851
- Sponsor's protocol ID
- GM2010-06-02
- Status last verified
- Jul 2019
- First submitted
- 28 Dec 2010
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22503395
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Large Multicentre Clinical Database and Biobank of Patients With Gynecologic Neoplasms
- ClinicalTrials.gov ID
- NCT01267851
- Acronym / sponsor ID
- GM2010-06-02
- Conditions
- Cervical Cancer, Ovarian Cancer, Endometrial Cancer, Choriocarcinoma, Uterine Myoma, Endometriosis
- Keywords
- gynecologic disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600,000 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- 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, Wuhan Central Hospital
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 29 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- patients with informed consent;
- patients with gynecologic diseases;
- patients with intact clinical and pathological information
Key exclusion criteria (1 listed)
- not included in the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Derived from this study: PubMed 22503395Hu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Cancer and Ovarian Cancer, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ma Ding, M.D. (86-27-8362681, dma@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01267851, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2019.