A Multi-omics Study of Adenomyosis

November 13, 2018 updated by: Lei Li

A Multi-omics Study on the Tumorigenesis of Adenomyosis

This study aims to analyze the multi-omics results between eutopic endometrium, adenomyosis and endometriosis of patients diagnosed of adenomyosis with and without endometriosis. The multi-omics profiles include whole exome sequencing, analysis of transcriptomics and metabolomics. A comprehensive multi-omics will reveal the pathogenesis of adenomyosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Lei Li

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

All patients with adenomyosis and/or endomtriosis and feasible for biopsy will be included.

Description

Inclusion Criteria:

  • Confirmed adenomyosis and/or endometriosis
  • Signed an approved informed consents
  • Feasible for biopsy

Exclusion Criteria:

  • Not meeting all of the inclusion criteria

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
Group of adenomyosis
Patients with adenomyosis with or without endometriosis
Combination product: A multi-omics analysis
A multi-omics analysis including whole exome sequencing, transcriptomics and metabolomics for eutopic and ectopic endometrium
Group of endometriosis
Patients with endometriosis without adenomyosis
Combination product: A multi-omics analysis
A multi-omics analysis including whole exome sequencing, transcriptomics and metabolomics for eutopic and ectopic endometrium
Group of control
Patients without adenomyosis or endometriosis
Combination product: A multi-omics analysis
A multi-omics analysis including whole exome sequencing, transcriptomics and metabolomics for eutopic and ectopic endometrium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequencies of somatic driving mutations
Time Frame: Two years
The differences of distributions and frequencies of somatic driving mutations will be compared between eutopic endometrium and ectopic endometrium by whole exome sequencing.
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequencies of alteration of RNA expression
Time Frame: Two years
The alteration of RNA expression, including mRNA, miRNA, and lncRNA, will be compared between eutopic endometrium and ectopic endometrium by transcriptome sequencing.
Two years
Frequencies of alteration of protein expression and signal pathway
Time Frame: Two years
The alteration of protein expression and signal pathway will be compared between eutopic endometrium and ectopic endometrium by metabolomic sequencing
Two years
Progression-free survival
Time Frame: Five years
Progression-free survival between patients with differential expressed multi-omics will be compared.
Five years

Collaborators and Investigators

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

Sponsor

Lei Li

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 (ACTUAL)

November 10, 2018

Primary Completion (ANTICIPATED)

November 23, 2020

Study Completion (ANTICIPATED)

November 23, 2020

Study Registration Dates

First Submitted

November 9, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (ACTUAL)

November 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 15, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AM-OMICS

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.

Clinical Trials on Endometriosis

Clinical Trials on A multi-omics analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe