A Multi-omics Study of Adenomyosis

• Conditions: Genomics; Endometriosis; Ectopic Endometrium; Metabolomics; Adenomyosis; Eutopic Endometrium; Transcriptomics
• Interventions: Combination Product: A multi-omics analysis

• Registration Number: NCT03742843
• Lead Sponsor: Lei Li

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-09
• Study Start: 2018-11-10
• Study First Submitted QC: 2018-11-13
• Last Update Submitted: 2018-11-13
• Study First Posted: 2018-11-15
• Last Update Posted: 2018-11-15
• Primary Completion: 2020-11-23
• Study Completion: 2020-11-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group of control	A multi-omics analysis	Patients without adenomyosis or endometriosis
Group of endometriosis	A multi-omics analysis	Patients with endometriosis without adenomyosis
Group of adenomyosis	A multi-omics analysis	Patients with adenomyosis with or without endometriosis

Primary Outcome Measures

Name	Time	Method
Frequencies of somatic driving mutations	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Lei Li; 🇨🇳 Beijing, Beijing, China