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 range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of somatic cancer driver mutations in progesterone-resistant versus progesterone-sensitive endometriosis lesions.