A Multi-omics Study of Adenomyosis

Endometriosis Clinical Trial

Official title:

A Multi-omics Study on the Tumorigenesis of Adenomyosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03742843
• Other study ID #: AM-OMICS
• Status: Recruiting
• Start date: November 10, 2018
• Est. completion date: November 23, 2020

Study information

• Verified date: November 2018
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, M.D.
• Phone: 13911988831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 23, 2020
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed adenomyosis and/or endometriosis

• Signed an approved informed consents

• Feasible for biopsy

Exclusion Criteria:

• Not meeting all of the inclusion criteria

Related Conditions & MeSH terms

• Adenomyosis
• Ectopic Endometrium
• Endometriosis
• Eutopic Endometrium
• Genomics
• Metabolomics
• Transcriptomics

Intervention

Combination Product:
• A multi-omics analysis
A multi-omics analysis including whole exome sequencing, transcriptomics and metabolomics for eutopic and ectopic endometrium

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequencies of somatic driving mutations	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	Frequencies of alteration of RNA expression	The alteration of RNA expression, including mRNA, miRNA, and lncRNA, will be compared between eutopic endometrium and ectopic endometrium by transcriptome sequencing.	Two years
Secondary	Frequencies of alteration of protein expression and signal pathway	The alteration of protein expression and signal pathway will be compared between eutopic endometrium and ectopic endometrium by metabolomic sequencing	Two years
Secondary	Progression-free survival	Progression-free survival between patients with differential expressed multi-omics will be compared.	Five years