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Could a simpler surgery be safer for aggressive uterine cancer?

NCT ID NCT06900582

Disease control Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two surgical approaches for women with early-stage, high-risk endometrial cancer that has a p53 gene mutation. One group will get the standard extensive lymph node removal, while the other gets a less invasive sentinel node biopsy. The goal is to see if the simpler procedure is just as good at preventing cancer from coming back, with fewer side effects.

What this could mean

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

Active substance
Sentinel lymph node mapping (a less invasive surgical procedure to check for cancer spread)
What this could lead to
If successful, this could show that a less invasive surgery is safe for women with this aggressive type of endometrial cancer, reducing side effects like lymphedema.
What could go wrong
This is a relatively early-stage trial (Phase NA) with 374 participants. The less invasive approach might not catch all cancer spread, potentially leading to higher recurrence rates.

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 374 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Oct 2031

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: 1 . ≥ 18 years old 2. High-risk endometrial cancer, as defined by the ESGO-ESTRO 20211 histological and molecular classification, with p53 mutation confirmed on endometrial biopsy or curettage in the two months before the surgery 3. Magnetic Resonance Imaging (MRI) confirmed FIGO 2023 stage I and II endometrial cancer, i.e., confined to the uterine corpus, ovary and the cervical stroma. 4\. Participant with a scheduled surgical intervention (total hysterectomy and bilateral salpingo-oophorectomy, with omentectomy in the case of serous, carcinosarcoma and undifferenciated type EC) 5. Eligible for comprehensive lymphadenectomy by laparoscopy 6. Participant with a negative Positron Emission Tomography scan (PET-CT scan) for lymph node involvement in the two months before the intervention 7. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1 8. Participant able to provide written informed consent Exclusion Criteria: 1. Recurrent EC 2. Previous chemo-, radio, or endocrine therapy for EC 3. Any contra-indication to lymphadenectomy and/or chemotherapy 4. Any contraindication to laparoscopy 5. Any criteria, based on the investigator's judgment, that would contraindicate the surgical procedure (e.g., but not limited to, anesthetic risk, bleeding, significant comorbidities) 6. Any known disorder or circumstances making participation in trial and follow-up questionable 7. Patients with other malignancies for whom the disease(s) and/or associated treatment(s) might have an impact on the patient's cancer prognosis 8. Known HIV-infection or AIDS 9. Simultaneous participation in another interventional clinical trial 10. Within the exclusion period following participation in another interventional clinical trial 11. Patients with difficulties in reading or understanding French, or an inability to understand the delivered information 12. Patients in emergency medical situations 13. Patient under guardianship or limited guardianship

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrium neoplasm

As listed by the trial registrant

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

Endometrial cancer Gene, P53 Lymphadenectomy Sentinel lymph node biopsy (SLNB)

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.