Prospective Clinical Study of the Relationship Between Cancer Driving Mutations Found in Endometriotic Implants and the Development of Progesterone Resistance
Sponsor study identifier
Secondary identifiers
NIH
observational
135
1 country
3
Study Start
October 1, 2020
Actual (reported)Primary Completion
October 1, 2024
Actual (reported)Study Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 27, 2018
Actual (reported)November 28, 2018
Actual (reported)October 1, 2020
Actual (reported)October 1, 2024
Actual (reported)October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of somatic cancer driver mutations in progesterone-resistant versus progesterone-sensitive endometriosis lesions.
Whole exome sequencing 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.
Six month
Number of cancer driver mutations in eutopic versus ectopic endometrial tissue in control versus diseased subjects
Six month
Difference in DNA methylation PCR profile of endometriotic lesions in ectopic versus eutopic endometrium in control versus diseased subjects.
Six month
Clinical or surgical diagnosis of Endometriosis, patients undergoing surgical management 100 participants
No diagnosis of Endometriosis, Patients undergoing Laparoscopic Tubal Ligation 35 participants
Women between the ages of 18-45 undergoing surgical management for endometriosis as cases and women between ages of 18-45 years undergoing elective tubal ligation and no diagnosis of endometriosis.
Yale School of Medicine
New Haven, Connecticut, 06510, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21218, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Endometrial tissue from ectopic and eutopic sites and blood sample.
James Segars, MD, FACOG
Professor
First Submitted
November 27, 2018
First Posted
November 28, 2018
Study Start
October 1, 2020
Actual (reported)Primary Completion
October 1, 2024
Actual (reported)Research OutSmarts Endometriosis II Study
Contact the study team to confirm eligibility.
Study Completion
October 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 14, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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