Clinical trial · Observational
Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance
Prospective Clinical Study of the Relationship Between Cancer Driving Mutations Found in Endometriotic Implants and the Development of Progesterone Resistance
NCT03756480CI-TRIAL-00114155active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Diseases | — | UNRESOLVED | — |
| Endometriosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Case Group
- description
- Clinical or surgical diagnosis of Endometriosis, patients undergoing surgical management 100 participants
- label
- Control Group
- description
- No diagnosis of Endometriosis, Patients undergoing Laparoscopic Tubal Ligation 35 participants
Primary outcomes (1)
- measure
- Number of somatic cancer driver mutations in progesterone-resistant versus progesterone-sensitive endometriosis lesions.
- timeFrame
- Six month
- description
- Digital droplet PCR will be used to identify somatic cancer-driver mutations with the presence of at least one of KRAS or ARID1A or PIK3CA or PPP2R1A cancer-driver mutations to assess any difference between progesterone-resistant endometriosis and progesterone-sensitive endometriosis.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.