Construction of Gynecological Tumor Sample Library

Constructing a gynecological tumor samples library, which is open and can be accessed.

Study Overview

• Status: Not yet recruiting
• Conditions: Gynecologic Cancer

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 Type: Observational
• Enrollment (Estimated): 2500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with gynecologic cancer, including cervical cancer, endometrial cancer, ovarian cancer, vulva cancer, vaginal cancer, and other rare type gynecologic cancer.

Description

Inclusion Criteria:

1. An informed consent form was obtained. If the age is less than 18 years old, the consent form should be signed by the guardian.
2. Preoperative tumor burden assessment and intraoperative evaluation by the supervising physician (professor) suggest sampling is acceptable.
3. The research team believes that sampling is possible.
4. Having the relevant requirements for sample library storage.
5. Surgical treatment is performed at Peking Union Medical College Hospital.

Exclusion Criteria:

1. Not meeting all inclusion criteria.
2. The research team considers any circumstances or considerations that may hinder normal pathological evaluation.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
construction of Biobank	Biobank including gynecolgic cancer samples, including cervical cancer, endometrial cancer, ovarian cancer, vulva cancer, vaginal cancer, and others types	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploring the molecular mechanism based on biobank	Exploring the molecular mechanism of gynecological tumor pathogenesis based on biobank	3 year
Drug sensitivity detection based on biobank	Exploring drug sensitivity detection in gynecological tumors based on biobank	3 year

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 22, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Construction of tumor sample

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No