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A Multi-omics Study of Adenomyosis

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ClinicalTrials.gov Identifier: NCT03742843
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment
Adenomyosis Endometriosis Ectopic Endometrium Eutopic Endometrium Genomics Transcriptomics Metabolomics Combination Product: A multi-omics analysis

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Multi-omics Study on the Tumorigenesis of Adenomyosis
Actual Study Start Date : November 10, 2018
Estimated Primary Completion Date : November 23, 2020
Estimated Study Completion Date : November 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Progression-free survival [ Time Frame: Five years ]
    Progression-free survival between patients with differential expressed multi-omics will be compared.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with adenomyosis and/or endomtriosis and feasible for biopsy will be included.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not meeting all of the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742843


Contacts
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Contact: Lei Li, M.D. 13911988831 ext 86 lileigh@163.com

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    13911988831 ext 86    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Investigators
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Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital
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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03742843    
Other Study ID Numbers: AM-OMICS
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometriosis
Adenomyosis
Genital Diseases, Female
Uterine Diseases