RECRUITING

Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia

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

To assess the feasibility of an expedited referral process for the obese endometrial cancer or EIN patient from her gynecologic oncologist to the Brigham Center for Metabolic and Bariatric Surgery (CMBS) in order to undergo concurrent weight loss surgery and hysterectomy within 8 weeks of first appointment with a gynecologic oncologist (or 12 weeks for EIN patients).

Official Title

Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia

Quick Facts

Study Start:2021-08-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04839614

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
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female adults at least 18 years of age
  2. * A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities
  3. * Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN.
  1. * Younger than 18 years old
  2. * BMI \< 35
  3. * Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis
  4. * Pregnant participants will be excluded from this study.
  5. * Patients with contraindications to bariatric surgery will also be excluded.
  6. * include inability to read an English informed consent form, and unwillingness to provide informed consent.

Contacts and Locations

Study Contact

Colleen Feltmate, MD
CONTACT
617-732-8840
cfeltmate@bwh.harvard.edu

Principal Investigator

Colleen Feltmate, MD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Colleen Feltmate, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

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 Date2021-08-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-08-01
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Endometrial Carcinoma
  • Obesity
  • EIN
  • Endometrial Intraepithelial Neoplasia
  • Endometrial Cancer Stage I
  • Weight Loss Surgery
  • Bariatric Surgery

Additional Relevant MeSH Terms

  • Endometrial Carcinoma
  • Obesity
  • EIN
  • Endometrial Intraepithelial Neoplasia
  • Endometrial Cancer Stage I