Status:
ACTIVE_NOT_RECRUITING
Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Endometriosis
Endometrial Diseases
Eligibility:
FEMALE
18-45 years
Brief 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...
Detailed 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 con...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT03756480
Start Date
October 1 2020
End Date
October 1 2026
Last Update
June 26 2025
Active Locations (3)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06510
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21218
3
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232