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Can one surgery treat endometrial cancer and obesity together?

NCT ID NCT04839614

Disease control Sponsor: Dana-Farber Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether obese patients with endometrial cancer or a precancerous condition can safely undergo a hysterectomy and weight loss surgery at the same time. Researchers want to see if a fast-track referral process can get patients to surgery within 8 to 12 weeks of diagnosis. The study will measure how many patients complete the combined procedure and compare complication rates with national averages.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Concurrent laparoscopic hysterectomy and weight loss surgery
What this could lead to
If this works, it could offer a single recovery period for obese patients needing both cancer surgery and weight loss surgery, potentially improving long-term health and reducing cancer recurrence risk.
What could go wrong
This is a small feasibility study, not a large trial, so results may not apply broadly. Combining two major surgeries raises risks of complications, and the referral process may not work in other hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

endometrial carcinoma Endometrial Hyperplasia endometrium neoplasm Obesity obesity disorder stage I endometrioid carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

EIN Endometrial cancer stage I Endometrial carcinoma Endometrial intraepithelial neoplasia Obesity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

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