Gynecologic CancerNCT06155370
Construction of Gynecological Tumor Organoids
An observational study of Gynecologic Cancer and Organoid, run by Peking Union Medical College Hospital.
Trial summary
This study focuses on the construction of a biological sample library for organoids and tumor tissues in gynecological tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Gynecologic Cancer, Organoid
- What is being tested?
- construction of organoids from gynecological tumor
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Dec 2024
- 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 80 years
- Women only
- Adult, Older adult
Study population: Those diagnosed with gynecological oncology, including cervical cancer, endometrial cancer, ovarian cancer, vulva cancer, vaginal cancer, and gestational trophoblastic tumor.
Who may be able to join
- Age of 18 or older, an informed consent form is provided;
- The preoperative tumor burden assessment and intraoperative researcher team believe that sampling is feasible;
- Having relevant requirements for sample library storage;
- Surgical treatment at Peking Union Medical College Hospital.
Who cannot join
- Unable to meet all inclusion criteria;
- The research team considers any situations or considerations that may hinder normal pathological assessment.
About this study
This study focuses on the construction of a biological sample library for organoids and tumor tissues in gynecological tumors.
Read the detailed description
Explore the construction and maintenance of a large-scale queue of gynecological tumor organoids. Beijing Daxiang Technology Co., Ltd. provides corresponding technical support and chip design. Gynecological oncology center provides tumor samples, clinical information, and pathological support, and biological sample library provides technical support, storage space, and quality management.
- Conditions
- Gynecologic Cancer, Organoid
- Being tested
- construction of organoids from gynecological tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
construction of organoids from gynecological tumorOther
organoids construction
| Study group | Role | What they receive |
|---|---|---|
| cohort of cervical cancer organoids | organoids derived from cervical cancer Receives: Other: construction of organoids from gynecological tumor | |
| cohort of endometrial cancer organoids | organoids derived from endometrial cancer Receives: Other: construction of organoids from gynecological tumor | |
| cohort of ovarian cancer organoids | organoids derived from ovarian cancer Receives: Other: construction of organoids from gynecological tumor | |
| cohort of vulva cancer organoids | organoids derived from vulva cancer Receives: Other: construction of organoids from gynecological tumor | |
| cohort of vaginal cancer organoids | organoids derived from vaginal cancer Receives: Other: construction of organoids from gynecological tumor | |
| cohort of gestational trophoblastic tumor organoids | organoids derived from gestational trophoblastic tumor Receives: Other: construction of organoids from gynecological tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construction of BioBank
BioBank including organoids banks, tissue banks, PDX banks, immune cell banks, and primary banks from other tissue sources
Measured: one year
Secondary outcomes (2)
Drug sensitivity detection based on organoids banks
Exploring drug sensitivity detection in gynecological tumors based on organoid libraries
Measured: one year
Exploring the molecular mechanism based on organoids banks
Exploring the molecular mechanism of gynecological tumor pathogenesis based on organoid banks
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Li, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155370
- Sponsor's protocol ID
- K4903 G&O organoids
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2023
- Last updated
- 4 Dec 2023
- 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 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of Gynecological Tumor Organoids
- ClinicalTrials.gov ID
- NCT06155370
- Acronym / sponsor ID
- K4903 G&O organoids
- Conditions
- Gynecologic Cancer, Organoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 4 Dec 2023 (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.
This study focuses on the construction of a biological sample library for organoids and tumor tissues in gynecological tumors.
Detailed description
Explore the construction and maintenance of a large-scale queue of gynecological tumor organoids. Beijing Daxiang Technology Co., Ltd. provides corresponding technical support and chip design. Gynecological oncology center provides tumor samples, clinical information, and pathological support, and biological sample library provides technical support, storage space, and quality management.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| cohort of cervical cancer organoids | – | Other: construction of organoids from gynecological tumororganoids derived from cervical cancer |
| cohort of endometrial cancer organoids | – | Other: construction of organoids from gynecological tumororganoids derived from endometrial cancer |
| cohort of ovarian cancer organoids | – | Other: construction of organoids from gynecological tumororganoids derived from ovarian cancer |
| cohort of vulva cancer organoids | – | Other: construction of organoids from gynecological tumororganoids derived from vulva cancer |
| cohort of vaginal cancer organoids | – | Other: construction of organoids from gynecological tumororganoids derived from vaginal cancer |
| cohort of gestational trophoblastic tumor organoids | – | Other: construction of organoids from gynecological tumororganoids derived from gestational trophoblastic tumor |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Those diagnosed with gynecological oncology, including cervical cancer, endometrial cancer, ovarian cancer, vulva cancer, vaginal cancer, and gestational trophoblastic tumor.
Key inclusion criteria (4 listed)
- Age of 18 or older, an informed consent form is provided;
- The preoperative tumor burden assessment and intraoperative researcher team believe that sampling is feasible;
- Having relevant requirements for sample library storage;
- Surgical treatment at Peking Union Medical College Hospital.
Key exclusion criteria (2 listed)
- Unable to meet all inclusion criteria;
- The research team considers any situations or considerations that may hinder normal pathological assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| construction of organoids from gynecological tumororganoids construction | Other | cohort of cervical cancer organoids, cohort of endometrial cancer organoids, cohort of gestational trophoblastic tumor organoids, cohort of ovarian cancer organoids, cohort of vaginal cancer organoids, cohort of vulva cancer organoids |
Primary outcome
Construction of BioBank
Time frame: one year
BioBank including organoids banks, tissue banks, PDX banks, immune cell banks, and primary banks from other tissue sources
2 secondary outcomes
Drug sensitivity detection based on organoids banks
Time frame: one year
Exploring the molecular mechanism based on organoids banks
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer and Organoid, 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 4 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: status not confirmed, as of the sponsor's last update on 4 Dec 2023. 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?
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?
Construction of BioBank (time frame: one year). 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 4 Dec 2023.