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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03756480
Other study ID # IRB00188129
Secondary ID R01HD096147
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date October 1, 2026

Study information

Verified date August 2023
Source Johns Hopkins University
Contact James Segars, MD, FACOG
Phone 410-614-2000
Email jsegars2@jhmi.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will test the hypothesis that the molecular changes present in ectopic endometriosis lesions correlate with progesterone-resistant disease (using the criteria defined in this study) and are present in matched eutopic endometrium.


Description:

Tissues from 100 patients with endometriosis will be analyzed with droplet digital PCR (ddPCR) targeted sequencing and responders (n=50) will be compared to non-responders (n=50) after controlling confounding factors. From a subset of the 100 cases, whole exome sequencing (WES) and Methylation-Specific PCR (MSP)-based methylation profiling on microdissected epithelium and stroma will be performed in matched eutopic and ectopic tissues from 20 patients with known cancer-associated mutations or 20 controls.


Recruitment information / eligibility

Status Recruiting
Enrollment 135
Est. completion date October 1, 2026
Est. primary completion date October 1, 2026
Accepts healthy volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Signed informed consent. - Gender: female. - Age: 18-45 years at the time of signing consent. - Clinical or surgical diagnosis of endometriosis undergoing laparoscopy. - Controls may not have clinical or surgical diagnosis of endometriosis. - Regular menstrual cycles. - BMI between 18-40 kg/m2. - Sexually active or have had a previous vaginal exam that used a speculum. - English speaking Exclusion Criteria: - Use of any kind of steroidal therapy including oral contraceptives, Norplant, estrogen replacement/supplemental therapy, androgens (Danazol, Cyclomen, Danocrine, testosterone) or progesterone. She may not be taking or be on Celebrex. - Pregnant. - Presence of pelvic infection. - Mullerian anomalies with absence of a cervix. - History of cancer of the reproductive tract. - Presence of undiagnosed uterine bleeding. - Treatment with intrauterine device (IUD) or progestin-containing intrauterine device.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland
United States Vanderbilt University Medical Center Nashville Tennessee
United States Yale School of Medicine New Haven Connecticut

Sponsors (3)

Lead Sponsor Collaborator
Johns Hopkins University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of somatic cancer driver mutations in progesterone-resistant versus progesterone-sensitive endometriosis lesions. Digital droplet PCR will be used to identify somatic cancer-driver mutations with the presence of at least one of KRAS or ARID1A or PIK3CA or PPP2R1A cancer-driver mutations to assess any difference between progesterone-resistant endometriosis and progesterone-sensitive endometriosis. Six month
Secondary Number of cancer driver mutations in eutopic versus ectopic endometrial tissue in control versus diseased subjects Whole exome sequencing in a subset of patients with progesterone-resistant disease and controls will be done using TruSeq Amplicon Cancer Panel (Illumina) to assess the number of cancer driver mutations. Six month
Secondary Difference in DNA methylation PCR profile of endometriotic lesions in ectopic versus eutopic endometrium in control versus diseased subjects. DNA methylation profile of eutopic and ectopic endometrial tissue for cases and controls will be done using Raw Illumina 450K methylation array to assess for any difference. One month
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