NCT04839614Recruiting
Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 7 Apr 2021
- Start date
- 1 Aug 2021
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Dana-Farber Cancer Institute
- Diseases
- Obesity, Endometrial cancer
- NCT number
- NCT04839614
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Aug 2021 to the primary completion date, 30 Jun 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with contraindications to bariatric surgery will also be excluded.
- --This includes active smokers, prior bariatric surgery, active substance abuse, recent suicide attempt, bulimia nervosa, large abdominal hernias, or poorly controlled psychiatric illness
Other illness
- Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis
Age
- Younger than 18 years old
Other
- BMI \< 35
- Pregnant participants will be excluded from this study.
- include inability to read an English informed consent form, and unwillingness to provide informed consent.
Who the study is looking for
- Female adults at least 18 years of age
- A BMI of 35-39.99 and 1 or more severe obesity-related co-morbidities
- --including T2D,112 hypertension, hyperlipidemia, obstructive sleep apnea (OSA), obesity-hypoventilation syndrome (OHS), Pickwickian syndrome (a combination of OSA and OHS), nonalcoholic 4 fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), pseudotumor cerebri, gastroesophageal reflux disease (GERD), asthma, venous stasis disease, severe urinary incontinence, debilitating arthritis, or considerably impaired quality of life) OR a BMI ≥ 40
- Tissue diagnosis (usually endometrial biopsy) of grade 1 endometrial carcinoma or EIN.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.