NCT03756480

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 135 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: —

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.

Detailed description

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.

Conditions

• Endometriosis
• Endometrial Diseases

Timeline

• Start date: 2020-10-01
• Primary completion: 2024-10-01
• Completion: 2026-10-01
• First posted: 2018-11-28
• Last updated: 2025-06-26

Locations

3 sites across 1 country: United States