Gynecologic Malignant TumorNCT02166515
The Study of Massively Parallel Sequencing in Early Detection for Gynecologic Malignant Tumor
An observational study of Gynecologic Malignant Tumor, run by Zhiqing, Liang at 1 site in China.
Trial summary
As human aging, 50% of women will be faced with the threat of cancer, especially gynecological malignancies. Ovarian, cervical and endometrial cancer are three major gynecological malignancies. Read more about this study
- Who is it for?
- Ages 16 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Malignant Tumor
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Oct 2017
- 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 16 to 75 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The experiment group are patients with cervical cancer, ovarian cancer or endometrial cancer.While the control group are volunteers on the basis of informed consent.
Who may be able to join
- Female aging from 16 to 75-year old;
- Preoperative diagnosis of gynecologic malignancies;
- Have the ability to comply with Research programs;
- Voluntarily participate in the study and signed an informed consent form
Who cannot join
- The cases do not meet the inclusion criteria should be removed from,indicating the reason for excluding.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Obstetrics and Gynaecology, Southwest Hospital, Third Military
Chongqing, Chongqing Municipality, 400038
About this study
As human aging, 50% of women will be faced with the threat of cancer, especially gynecological malignancies. Ovarian, cervical and endometrial cancer are three major gynecological malignancies. In recent years, the incidence of cervical cancer, especially in young women significantly increased; ovarian cancer, although the incidence of malignant tumors in the female reproductive system ranked second, but its mortality rate already in the first place; and the morbidity and mortality of endometrial cancer is also rising.
The key to gynecologic malignancies is how to early diagnose and treat. With the advancement of science and technology, such as molecular biology techniques widely used in the medical field, early diagnosis, proper treatment and other aspects in gynecologic malignancies is expected to achieve a breakthrough. Genome-wide scan strategy, making the whole genome for linkage analysis for gynecological malignancies possible. Therefore, the investigators intend to find specific mutations to provide a new early screening approach for gynecological malignancies, which in later result in early diagnosis and specific treatment for gynecological malignant tumors.
- Conditions
- Gynecologic Malignant Tumor
- Keywords
- cervical cancer, ovarian cancer, endometrial cancer, high-throughput sequencing
- Medical subject headings
- Uterine Cervical Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| experiment group | patients with cervical cancer, endometrial cancers or ovary cancer | |
| control group | postmenopausal women with benign tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene mutation from species of cervical cancer, endometrial cancers and ovary cancer
We expect to found spcific DNA mutation in the species (peripheral blood, liquid Pap smear and cancer tissue) from cervical cancer, endometrial cancers and ovary.
Measured: 4 years
Secondary outcomes (1)
the difference between detection sensitivity
Comparing sensiitivity of the three kinds of samples on early detection of gynecologic malignancies
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2016 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic Malignant TumorStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiqing, Liang
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Huada Genomics Co., Ltd.
- Responsible party
- Sponsor-investigator, Zhiqing, Liang, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166515
- Sponsor's protocol ID
- 001
- Other IDs
- fck001
- Status last verified
- Jun 2014
- First submitted
- 10 Feb 2014
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Massively Parallel Sequencing in Early Detection for Gynecologic Malignant Tumor
- ClinicalTrials.gov ID
- NCT02166515
- Acronym / sponsor ID
- 001
- Conditions
- Gynecologic Malignant Tumor
- Keywords
- cervical cancer, ovarian cancer, endometrial cancer, high-throughput sequencing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhiqing, LiangUniversity, hospital or other
- Collaborators
- Shenzhen Huada Genomics Co., Ltd.
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 18 Jun 2014 (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.
As human aging, 50% of women will be faced with the threat of cancer, especially gynecological malignancies. Ovarian, cervical and endometrial cancer are three major gynecological malignancies. In recent years, the incidence of cervical cancer, especially in young women significantly increased; ovarian cancer, although the incidence of malignant tumors in the female reproductive system ranked second, but its mortality rate already in the first place; and the morbidity and mortality of endometrial cancer is also rising.
The key to gynecologic malignancies is how to early diagnose and treat. With the advancement of science and technology, such as molecular biology techniques widely used in the medical field, early diagnosis, proper treatment and other aspects in gynecologic malignancies is expected to achieve a breakthrough. Genome-wide scan strategy, making the whole genome for linkage analysis for gynecological malignancies possible. Therefore, the investigators intend to find specific mutations to provide a new early screening approach for gynecological malignancies, which in later result in early diagnosis and specific treatment for gynecological malignant tumors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment group | – | –patients with cervical cancer, endometrial cancers or ovary cancer |
| control group | – | –postmenopausal women with benign tumor |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The experiment group are patients with cervical cancer, ovarian cancer or endometrial cancer.While the control group are volunteers on the basis of informed consent.
Key inclusion criteria (4 listed)
- Female aging from 16 to 75-year old;
- Preoperative diagnosis of gynecologic malignancies;
- Have the ability to comply with Research programs;
- Voluntarily participate in the study and signed an informed consent form
Key exclusion criteria (1 listed)
- The cases do not meet the inclusion criteria should be removed from,indicating the reason for excluding.
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
Gene mutation from species of cervical cancer, endometrial cancers and ovary cancer
Time frame: 4 years
We expect to found spcific DNA mutation in the species (peripheral blood, liquid Pap smear and cancer tissue) from cervical cancer, endometrial cancers and ovary.
1 secondary outcome
the difference between detection sensitivity
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gynecologic Malignant Tumor, run by Zhiqing, Liang 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 4 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 18 Jun 2014. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene mutation from species of cervical cancer, endometrial cancers and ovary cancer (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2014.