A Multiomics Study Based on the Dynamic Evolution of Endometrial Carcinogenesis

NCT06007300 | Not Yet Recruiting

• 1 other identifier: LY-2023-136-B
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

the Dynamic Evolution of Endometrial Carcinogenesis; Multiomics Analysis

Keywords

Dynamic Evolution; Genomics; Transcriptome; Proteomics; Metabolomics

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Normal Group

Patients with normal endometrium

Precancerous Group

Patients with atypical hyperplasia of endometrium

Carcinoma Group

Patients with endometrial cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with normal endometrium (requiring diagnostic or therapeutic hysteroscopy or hysterectomy for other reasons), patients with precancerous lesions of endometrium, and patients with endometrial cancer who underwent surgery in the gynecology and obstetrics department of Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine, whose illness was diagnosed as normal endometrium, atypical hyperplasia endometrium, or endometrial cancer by pathology.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 23, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 23, 2023

Record last verified: 2023-08