Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance

Last updated: August 6, 2024
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometriosis

Uterine Disorders

Treatment

N/A

Clinical Study ID

NCT03756480
IRB00188129
R01HD096147
  • Ages 18-45
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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 intrauterinedevice.

Study Design

Total Participants: 135
Study Start date:
October 01, 2020
Estimated Completion Date:
October 01, 2026

Study 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.

Connect with a study center

  • Yale School of Medicine

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

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