Endometrial CarcinomaNCT04839614
Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
A study testing CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral in people with Endometrial Carcinoma and Obesity, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Carcinoma, Obesity, EIN
- What is being tested?
- CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2021to 30 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Younger than 18 years old
- BMI < 35
- Without a tissue diagnosis, or with a grade 2 or greater endometrial cancer tissue diagnosis
- Pregnant participants will be excluded from this study.
- 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
- include inability to read an English informed consent form, and unwillingness to provide informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Colleen Feltmate, MD
Colleen Feltmate, MD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Colleen Feltmate, MD
About this study
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).
Read the detailed description
The most common risk factor for endometrial cancer is obesity. However, because early-stage endometrial cancer has a very high survival rate, patients more often suffer from long-term issues related to their weight, like heart disease, stroke, and diabetes. Weight loss surgery has been shown to help patients lose weight and also decrease their risk for obesity-related diseases.
This research study is a Feasibility Study. This is the first-time investigators are studying both 1) the referral process of patients with endometrial cancer to the Center for Metabolic and Bariatric Surgery without delaying curative treatment of endometrial cancer 2) the combined surgery of both hysterectomy and weight loss surgery. The combined surgery of hysterectomy and weight loss surgery has been performed both at this institution and others without increased complications, but it has not been formally studied.
Approximately 30 patients are expected to participate in this study at Brigham and Women's Hospital (BWH).
- Conditions
- Endometrial Carcinoma, Obesity, EIN, Endometrial Intraepithelial Neoplasia, Endometrial Cancer Stage I
- Being tested
- CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral
- Keywords
- Endometrial Carcinoma, Obesity, EIN, Endometrial Intraepithelial Neoplasia, Endometrial Cancer Stage I, Weight Loss Surgery, Bariatric Surgery
- Medical subject headings
- Endometrial Neoplasms, Obesity, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-ReferralOther
See arm description
| Study group | Role | What they receive |
|---|---|---|
| CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY | Experimental | Upon enrollment in the study at first appointment with gynecologic oncologist, referral to the BWH Center for Metabolic and Bariatric Surgery (CMBS).
* Schedule a series of appointments with a bariatric surgeon, nutritionist and psychologist, which is part of the approval process for weight loss surgery.
* Hysterectomy and weight loss surgery will then be scheduled on the same day within 8 weeks from first visit with the gynecologic oncologist for endometrial cancer or 12 weeks if you have endometrial pre-cancer.
* Series of post-operative visits with the bariatric surgeon and gynecologic oncologic surgeon as well as the nutritionist and psychologist. Receives: Other: CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients who schedule an appointment and speak with a surgeon 1-2 weeks after enrollment
50% of the patients utilize the referral system and attend an initial consultation, it will be considered feasible
Measured: 2 Weeks
proportion of patients who undergo the concurrent surgeries within 8 weeks of diagnosis (12 weeks for EIN patients)
concurrent surgery will be considered feasible if 50% (7-8 patients) of patients who undergo an initial consultation at the CMBS actually undergo concurrent surgery within 8 weeks of diagnosis (or 12 weeks for EIN).
Measured: up 12 weeks
Secondary outcomes (7)
Safety of the concurrent surgeries
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Measured: 3 weeks
Postoperative complications
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Measured: 3 weeks
Time under anesthesia
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Measured: 1 Day
Total time in operating room
compare our safety outcomes with national complication rates for each individual surgery to assess the safety of the patient population
Measured: 1 Day
Postoperative weight loss
Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses
Measured: 6 months, 1 year
Changes in lab values reflecting comorbid conditions
Paired t-test or Wilcoxon rank sum test will be used to compare pre- and post-surgical outcomes and survey responses
Measured: 6 months, 1 year
Post Operative 12-item Short Form Healthy Survey (SF-12) Survey
12-item Short Form Healthy Survey (SF-12) Survey
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Aug 2021
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Feltmate, MD, Brigham and Women's Hospital
- Investigators
- Colleen Feltmate, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839614
- Sponsor's protocol ID
- 19-419
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2021
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.