Concurrent Laparoscopic Hysterectomy and Weight Loss Surgery in Obese Patients With Endometrial Carcinoma or Endometrial Intraepithelial Neoplasia
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a faster referral process can help patients have weight loss surgery and surgery to remove the uterus at the same time. It is for adult women with obesity and grade 1 cancer of the uterus lining or EIN, abnormal cells in that lining. The goal is surgery within 8 weeks of the first cancer specialist visit, or 12 weeks for patients with EIN.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 18 or older.
- A body mass index (BMI), a measure of weight compared with height, of 40 or higher; or a BMI of 35–39.99 with at least one serious health problem linked to obesity.
- A tissue test showing grade 1 cancer of the uterus lining or EIN, abnormal cells in that lining.
Who can't join
- Younger than 18.
- BMI below 35.
- No tissue test confirming the diagnosis, or a tissue test showing grade 2 or higher cancer of the uterus lining.
- Pregnant.
- Cannot safely have weight loss surgery. Reasons include current smoking, past weight loss surgery, current substance abuse, or large hernias in the belly.
- A recent suicide attempt, bulimia (an eating disorder), or a mental health condition that is not well controlled.
- Cannot read the English consent form or are not willing to give consent to join.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Study sites (2)
MA
- Brigham and Women's Hospital · Boston, MA 02115Colleen Feltmate, MD · Study contactColleen Feltmate, MD · Principal investigatorMore trials in Boston
- Dana-Farber Cancer Institute · Boston, MA 02215Colleen Feltmate, MD · Principal investigatorMore trials in Boston