Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03756480|
Recruitment Status : Not yet recruiting
First Posted : November 28, 2018
Last Update Posted : September 16, 2019
|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|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||November 2025|
|Estimated Study Completion Date :||November 2025|
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
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, FACOGemail@example.com|
|Contact: Bhuchitra Singh, MBBS,MPH,MSfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Hospital||Not yet 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, MBBS,MPH,MS|
|Principal Investigator:||James Segars, MD, FACOG||Professor|