A Multiomics Study Based on the Dynamic Evolution of Endometrial Carcinogenesis

Sponsor

RenJi Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06007300

Collaborator

(none)

300

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this observational study is to draw the characteristic maps of imaging omics, genomics, transcriptome, proteomics, pathological omics, metabolomics, etc. of the dynamic evolution of endometrial carcinogenesis in 100 patients with normal endometrium, 100 patients with atypical endometrial hyperplasia, and 100 patients with endometrial cancer; and then to explore the underlying molecular mechanism, and establish the database system for the dynamic evolution of endometrial carcinogenesis.

Condition or Disease	Intervention/Treatment	Phase
the Dynamic Evolution of Endometrial Carcinogenesis Multiomics Analysis

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Multiomics Study Based on the Dynamic Evolution of Endometrial Carcinogenesis

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Normal Group Patients with normal endometrium
Precancerous Group Patients with atypical hyperplasia of endometrium
Carcinoma Group Patients with endometrial cancer

Outcome Measures

Primary Outcome Measures

The mutant genes of participants and their expression as assessed by gene sequencing, RNA sequencing and mass spectrometry analysis [August 2023 to June 2026]
Differences in the expression of these mutant genes among the three groups of participants as assessed by SAS® 9.4 [January 2026 to June 2026]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Pathological diagnosis: normal endometrium, atypical hyperplasia endometrium, or endometrial cancer;
Obtain pathological results after undergoing hysteroscopic surgery or hysterectomy;
The patient voluntarily participated in this research project with good compliance and was able to complete the enrollment according to the experimental requirements;
Sign the informed consent form and consent to the collection and use of their data, and consent to genomics, transcriptome and other tests.

Exclusion Criteria:

Patients with malignant tumors in other parts of the body;
Suffering from uncontrollable neurological diseases, psychiatric diseases, or psychiatric disorders;
Poor compliance and inability to cooperate and describe treatment responders.