Gynecologic CancerNCT06204354
Construction of Gynecological Tumor Sample Library
An observational study of Gynecologic Cancer, run by Peking Union Medical College Hospital.
Trial summary
Constructing a gynecological tumor samples library, which is open and can be accessed. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Gynecologic Cancer
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- Women only
- Adult, Older adult
Study population: Patients diagnosed with gynecologic cancer, including cervical cancer, endometrial cancer, ovarian cancer, vulva cancer, vaginal cancer, and other rare type gynecologic cancer.
Who may be able to join
- An informed consent form was obtained. If the age is less than 18 years old, the consent form should be signed by the guardian.
- Preoperative tumor burden assessment and intraoperative evaluation by the supervising physician (professor) suggest sampling is acceptable.
- The research team believes that sampling is possible.
- Having the relevant requirements for sample library storage.
- Surgical treatment is performed at Peking Union Medical College Hospital.
Who cannot join
- Not meeting all inclusion criteria.
- The research team considers any circumstances or considerations that may hinder normal pathological evaluation.
About this study
Constructing a gynecological tumor samples library, which is open and can be accessed.
Read the detailed description
This project is the construction and maintenance of a gynecological tumor sample library. It is supported by the National Key Laboratory of Difficult, Severe, and Rare Diseases at Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences. This project will lay a clinical specimen foundation for exploring the molecular mechanisms of gynecological tumors in the future.
- Conditions
- Gynecologic Cancer
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 |
|---|---|---|
| samples of cervical cancer | fresh samples collected from patients diagnosed with cervical cancer | |
| samples of endometrial cancer | fresh samples collected from patients diagnosed with endometrial cancer | |
| samples of ovarian cancer | fresh samples collected from patients diagnosed with ovarian cancer | |
| samples of vulva cancer | fresh samples collected from patients diagnosed with vulva cancer | |
| samples of vaginal cancer | fresh samples collected from patients diagnosed with vaginal cancer | |
| samples of rare gynecological cancer | fresh samples collected from patients diagnosed with rare gynecological cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
construction of Biobank
Biobank including gynecolgic cancer samples, including cervical cancer, endometrial cancer, ovarian cancer, vulva cancer, vaginal cancer, and others types
Measured: 3 years
Secondary outcomes (2)
Exploring the molecular mechanism based on biobank
Exploring the molecular mechanism of gynecological tumor pathogenesis based on biobank
Measured: 3 year
Drug sensitivity detection based on biobank
Exploring drug sensitivity detection in gynecological tumors based on biobank
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204354
- Sponsor's protocol ID
- Construction of tumor sample
- Status last verified
- Dec 2023
- First submitted
- 22 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Gynecological Tumor Sample Library
- ClinicalTrials.gov ID
- NCT06204354
- Acronym / sponsor ID
- Construction of tumor sample
- Conditions
- Gynecologic Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 12 Jan 2024 (actual)
- 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.
Constructing a gynecological tumor samples library, which is open and can be accessed.
Detailed description
This project is the construction and maintenance of a gynecological tumor sample library. It is supported by the National Key Laboratory of Difficult, Severe, and Rare Diseases at Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences. This project will lay a clinical specimen foundation for exploring the molecular mechanisms of gynecological tumors in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| samples of cervical cancer | – | –fresh samples collected from patients diagnosed with cervical cancer |
| samples of endometrial cancer | – | –fresh samples collected from patients diagnosed with endometrial cancer |
| samples of ovarian cancer | – | –fresh samples collected from patients diagnosed with ovarian cancer |
| samples of vulva cancer | – | –fresh samples collected from patients diagnosed with vulva cancer |
| samples of vaginal cancer | – | –fresh samples collected from patients diagnosed with vaginal cancer |
| samples of rare gynecological cancer | – | –fresh samples collected from patients diagnosed with rare gynecological cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with gynecologic cancer, including cervical cancer, endometrial cancer, ovarian cancer, vulva cancer, vaginal cancer, and other rare type gynecologic cancer.
Key inclusion criteria (5 listed)
- An informed consent form was obtained. If the age is less than 18 years old, the consent form should be signed by the guardian.
- Preoperative tumor burden assessment and intraoperative evaluation by the supervising physician (professor) suggest sampling is acceptable.
- The research team believes that sampling is possible.
- Having the relevant requirements for sample library storage.
- Surgical treatment is performed at Peking Union Medical College Hospital.
Key exclusion criteria (2 listed)
- Not meeting all inclusion criteria.
- The research team considers any circumstances or considerations that may hinder normal pathological evaluation.
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
construction of Biobank
Time frame: 3 years
Biobank including gynecolgic cancer samples, including cervical cancer, endometrial cancer, ovarian cancer, vulva cancer, vaginal cancer, and others types
2 secondary outcomes
Exploring the molecular mechanism based on biobank
Time frame: 3 year
Drug sensitivity detection based on biobank
Time frame: 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer, run by Peking Union Medical College Hospital.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
construction of Biobank (time frame: 3 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 12 Jan 2024.