Construction of Gynecological Tumor Organoids

November 23, 2023 updated by: Lei Li, Peking Union Medical College Hospital
This study focuses on the construction of a biological sample library for organoids and tumor tissues in gynecological tumors.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Age of 18 or older, an informed consent form is provided;
  2. The preoperative tumor burden assessment and intraoperative researcher team believe that sampling is feasible;
  3. Having relevant requirements for sample library storage;
  4. Surgical treatment at Peking Union Medical College Hospital.

Exclusion Criteria:

  1. Unable to meet all inclusion criteria;
  2. The research team considers any situations or considerations that may hinder normal pathological assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cohort of cervical cancer organoids
organoids derived from cervical cancer
Other: construction of organoids from gynecological tumor
organoids construction
cohort of endometrial cancer organoids
organoids derived from endometrial cancer
Other: construction of organoids from gynecological tumor
organoids construction
cohort of ovarian cancer organoids
organoids derived from ovarian cancer
Other: construction of organoids from gynecological tumor
organoids construction
cohort of vulva cancer organoids
organoids derived from vulva cancer
Other: construction of organoids from gynecological tumor
organoids construction
cohort of vaginal cancer organoids
organoids derived from vaginal cancer
Other: construction of organoids from gynecological tumor
organoids construction
cohort of gestational trophoblastic tumor organoids
organoids derived from gestational trophoblastic tumor
Other: construction of organoids from gynecological tumor
organoids construction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug sensitivity detection based on organoids banks
Time Frame: one year
Exploring drug sensitivity detection in gynecological tumors based on organoid libraries
one year
Exploring the molecular mechanism based on organoids banks
Time Frame: one year
Exploring the molecular mechanism of gynecological tumor pathogenesis based on organoid banks
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

November 23, 2023

First Posted (Actual)

December 4, 2023

Study Record Updates

Last Update Posted (Actual)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • K4903 G&O organoids

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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