Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance (NCT03756480) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance
United States135 participantsStarted 2020-10-01
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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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.
What they're measuring
1
Number of somatic cancer driver mutations in progesterone-resistant versus progesterone-sensitive endometriosis lesions.