ACTIVE_NOT_RECRUITING

Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Clinical Study of the Relationship Between Cancer Driving Mutations Found in Endometriotic Implants and the Development of Progesterone Resistance

Quick Facts

Study Start:2020-10-01
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03756480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed informed consent.
  2. * Gender: female.
  3. * Age: 18-45 years at the time of signing consent.
  4. * Clinical or surgical diagnosis of endometriosis undergoing laparoscopy.
  5. * Controls may not have clinical or surgical diagnosis of endometriosis.
  6. * Regular menstrual cycles.
  7. * BMI between 18-40 kg/m2.
  8. * Sexually active or have had a previous vaginal exam that used a speculum.
  9. * English speaking
  1. * 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.
  2. * Pregnant.
  3. * Presence of pelvic infection.
  4. * Mullerian anomalies with absence of a cervix.
  5. * History of cancer of the reproductive tract.
  6. * Presence of undiagnosed uterine bleeding.
  7. * Treatment with intrauterine device (IUD) or progestin-containing intrauterine device.

Contacts and Locations

Principal Investigator

James Segars, MD, FACOG
PRINCIPAL_INVESTIGATOR
Professor

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • James Segars, MD, FACOG, PRINCIPAL_INVESTIGATOR, Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-01
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2020-10-01
Study Completion Date2026-10-01

Terms related to this study

Keywords Provided by Researchers

  • Endometriosis

Additional Relevant MeSH Terms

  • Endometriosis
  • Endometrial Diseases