Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance
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|ClinicalTrials.gov Identifier: NCT03756480|
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : August 8, 2022
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|Condition or disease|
|Endometriosis Endometrial Diseases|
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.
|Study Type :||Observational|
|Estimated Enrollment :||135 participants|
|Official Title:||Prospective Clinical Study of the Relationship Between Cancer Driving Mutations Found in Endometriotic Implants and the Development of Progesterone Resistance|
|Actual Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||October 1, 2026|
|Estimated Study Completion Date :||October 1, 2026|
Clinical or surgical diagnosis of Endometriosis, patients undergoing surgical management
No diagnosis of Endometriosis, Patients undergoing Laparoscopic Tubal Ligation
- Number of somatic cancer driver mutations in progesterone-resistant versus progesterone-sensitive endometriosis lesions. [ Time Frame: Six month ]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.
- Number of cancer driver mutations in eutopic versus ectopic endometrial tissue in control versus diseased subjects [ Time Frame: Six month ]Whole exome sequencing in a subset of patients with progesterone-resistant disease and controls will be done using TruSeq Amplicon Cancer Panel (Illumina) to assess the number of cancer driver mutations.
- Difference in DNA methylation PCR profile of endometriotic lesions in ectopic versus eutopic endometrium in control versus diseased subjects. [ Time Frame: One month ]DNA methylation profile of eutopic and ectopic endometrial tissue for cases and controls will be done using Raw Illumina 450K methylation array to assess for any difference.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Sampling Method:||Probability Sample|
- 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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756480
|Contact: James Segars, MD, FACOGfirstname.lastname@example.org|
|Contact: Bhuchitra Singh, MD, MPH, MSemail@example.com|
|United States, Connecticut|
|Yale School of Medicine||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Hugh Taylor, MD|
|Contact: Luisa Coraluzzi, BSN 203-785-2164 firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21218|
|Sub-Investigator: Ie Ming Shih, MD, PhD|
|Sub-Investigator: Tian-Li Wang, PhD|
|Sub-Investigator: Maria Facadio Antero, MD|
|Sub-Investigator: Bhuchitra Singh, MD, MPH, MS|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Kaylon Bruner-Tran, PhD|
|Contact: Kevin Osteen, PhD|
|Principal Investigator:||James Segars, MD, FACOG||Professor|
|Responsible Party:||Johns Hopkins University|
|Other Study ID Numbers:||
R01HD096147 ( U.S. NIH Grant/Contract )
|First Posted:||November 28, 2018 Key Record Dates|
|Last Update Posted:||August 8, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|