NCT03742843

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2020

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

November 9, 2018

Last Update Submit

November 13, 2018

Conditions

AdenomyosisEndometriosisEctopic EndometriumEutopic EndometriumGenomicsTranscriptomicsMetabolomics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Frequencies of alteration of RNA expression

    Two years

  • Frequencies of alteration of protein expression and signal pathway

    Two years

  • Progression-free survival

    Five years

Study Arms (3)

Group of adenomyosis

Patients with adenomyosis with or without endometriosis

Combination Product: A multi-omics analysis

Group of endometriosis

Patients with endometriosis without adenomyosis

Combination Product: A multi-omics analysis

Group of control

Patients without adenomyosis or endometriosis

Combination Product: A multi-omics analysis

Interventions

A multi-omics analysisCOMBINATION_PRODUCT

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

Group of adenomyosisGroup of controlGroup of endometriosis

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

An 8 ml peripheral venous blood, and 50 μL adenomyosis/endometriosis tissue and tissue adjacent to adenomyosis/endometriosis will be collected from eligible patients.

MeSH Terms

Conditions

AdenomyosisEndometriosis

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Lei Li, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

13911988831lileigh@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 9, 2018

First Posted

November 15, 2018

Study Start

November 10, 2018

Primary Completion

November 23, 2020

Study Completion

November 23, 2020

Last Updated

November 15, 2018

Record last verified: 2018-11

Locations

CN(1)