NCT06155370

Brief Summary

This study focuses on the construction of a biological sample library for organoids and tumor tissues in gynecological tumors.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

November 23, 2023

Last Update Submit

November 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Construction of BioBank

    BioBank including organoids banks, tissue banks, PDX banks, immune cell banks, and primary banks from other tissue sources

    one year

Secondary Outcomes (2)

  • Drug sensitivity detection based on organoids banks

    one year

  • Exploring the molecular mechanism based on organoids banks

    one year

Study Arms (6)

cohort of cervical cancer organoids

organoids derived from cervical cancer

Other: construction of organoids from gynecological tumor

cohort of endometrial cancer organoids

organoids derived from endometrial cancer

Other: construction of organoids from gynecological tumor

cohort of ovarian cancer organoids

organoids derived from ovarian cancer

Other: construction of organoids from gynecological tumor

cohort of vulva cancer organoids

organoids derived from vulva cancer

Other: construction of organoids from gynecological tumor

cohort of vaginal cancer organoids

organoids derived from vaginal cancer

Other: construction of organoids from gynecological tumor

cohort of gestational trophoblastic tumor organoids

organoids derived from gestational trophoblastic tumor

Other: construction of organoids from gynecological tumor

Interventions

organoids construction

cohort of cervical cancer organoidscohort of endometrial cancer organoidscohort of gestational trophoblastic tumor organoidscohort of ovarian cancer organoidscohort of vaginal cancer organoidscohort of vulva cancer organoids

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Those diagnosed with gynecological oncology, including cervical cancer, endometrial cancer, ovarian cancer, vulva cancer, vaginal cancer, and gestational trophoblastic tumor.

You may qualify if:

  • 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.

You may not qualify if:

  • The research team considers any situations or considerations that may hinder normal pathological assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen obtained from patients diagnosed with gynecological cancer from the cancer site.

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 4, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

December 4, 2023

Record last verified: 2023-11