Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Women's Studies, Endometriosis |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 11/30/2018 |
| Start Date: | April 15, 2019 |
| End Date: | December 15, 2025 |
| Contact: | James Segars, MD, FACOG |
| Email: | jsegars2@jhmi.edu |
| Phone: | 410-614-2000 |
Prospective Clinical Study of the Relationship Between Cancer Driving Mutations Found in Endometriotic Implants and the Development of Progesterone Resistance
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.
endometriosis lesions correlate with progesterone-resistant disease (using the criteria
defined in this study) and are present in matched eutopic endometrium.
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 confounding factors.
From a subset of the 100 cases, whole exome sequencing (WES) and Methylation-Specific PCR
(MSP)-based methylation profiling on microdissected epithelium and stroma will be performed
in matched eutopic and ectopic tissues from 20 patients with known cancer-associated
mutations or 20 controls.
(ddPCR) targeted sequencing and responders (n=50) will be compared to non-responders (n=50)
after controlling confounding factors.
From a subset of the 100 cases, whole exome sequencing (WES) and Methylation-Specific PCR
(MSP)-based methylation profiling on microdissected epithelium and stroma will be performed
in matched eutopic and ectopic tissues from 20 patients with known cancer-associated
mutations or 20 controls.
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.
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