Investigating mutations in endometriosis lesions and progesterone resistance
Prospective Clinical Study of the Relationship Between Cancer Driving Mutations Found in Endometriotic Implants and the Development of Progesterone Resistance
Johns Hopkins University · NCT03756480
This study is trying to see how changes in endometriosis tissue might affect treatment response to progesterone in women with the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 135 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Johns Hopkins University (other) |
| Locations | 3 sites (New Haven, Connecticut and 2 other locations) |
| Trial ID | NCT03756480 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the molecular changes in ectopic endometriosis lesions and their correlation with progesterone resistance. It will analyze tissue samples from 100 patients diagnosed with endometriosis, comparing responders and non-responders to treatment. Advanced techniques such as droplet digital PCR and whole exome sequencing will be employed to identify cancer-associated mutations and other relevant molecular characteristics in matched eutopic and ectopic tissues.
Who should consider this trial
Good fit: Ideal candidates are females aged 18-45 with a clinical or surgical diagnosis of endometriosis undergoing laparoscopy.
Not a fit: Patients with a history of reproductive tract cancer or those currently using steroidal therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for women suffering from endometriosis and progesterone resistance.
How similar studies have performed: Other studies have shown promise in understanding endometriosis through molecular analysis, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New Haven, Connecticut and 2 other locations
- Yale School of Medicine — New Haven, Connecticut, United States (RECRUITING)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (RECRUITING)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: James Segars, MD, FACOG — Professor
- Study coordinator: James Segars, MD, FACOG
- Email: jsegars2@jhmi.edu
- Phone: 410-614-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endometriosis, Endometrial Diseases