A Multiomics Study Based on the Dynamic Evolution of Endometrial Carcinogenesis

August 17, 2023 updated by: RenJi Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

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

No

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.

Description

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.

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
Normal Group
Patients with normal endometrium
Precancerous Group
Patients with atypical hyperplasia of endometrium
Carcinoma Group
Patients with endometrial cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The mutant genes of participants and their expression as assessed by gene sequencing, RNA sequencing and mass spectrometry analysis
Time Frame: August 2023 to June 2026
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
Time Frame: January 2026 to June 2026
January 2026 to June 2026

Collaborators and Investigators

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

Sponsor

RenJi 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)

August 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY-2023-136-B

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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