Large study aims to pinpoint cancer return rates and swelling risks after treatment
NCT ID NCT04291612
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This study is observing about 1,715 people with early-stage endometrial cancer to see how often the cancer comes back and how often lymphedema (swelling) happens after standard treatment. Participants will have regular check-ups for 36 months. The goal is to gather real-world data to improve future care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this trial could provide clearer data on recurrence rates and lymphedema risks after standard endometrial cancer treatment, helping doctors and patients make more informed decisions.
- What could go wrong
- This is an observational study, not testing a new treatment. It cannot prove that any intervention works better than current care. Results may not apply to all patients.
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.
- Participants
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About 1,715 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2020
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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.
Who is studied
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or a member of the research teams. If the investigator is a member of the treatment team, s/he will screen their patients' medical records for suitable research study participants and discuss the study and their potential for enrolling in the research study. Potential subjects contacted by their treating physician will be referred to the investigator/research staff of the study. The principal investigators may also screen the medical records of patients with whom they do not have a treatment relationship for the limited purpose of identifying patients who would be eligible to enroll in the study, and to record appropriate contact information in order to approach these patients regarding the possibility of enrolling in the study. Patients identified in this manner would subsequently be approached for study enrollment after consultation with their treating physician.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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.
Screening Inclusion Criteria: * ECOG performance status 0-1 or KPS ≥ 70% * Age ≥ 18 years * Endometrioid adenocarcinoma histologic diagnosis on endometrial biopsy or dilatation and curettage * No evidence of extrauterine disease, or suspicious pelvic lymph nodes, or distant metastases, or cervical invasion on pre-operative conventional imaging studies (Pelvic +/- Abdomen CT or MRI or sonogram, or body PET scan) and physical examination (uterine confined by exam and imaging ) * Suitable candidate for surgery * Planned surgical treatment including hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy * No history of second primary cancer (invasive or in situ) within the past 5 years, not including non-melanoma skin cancer * Approved and signed informed consent * No history of neoadjuvant chemotherapy or radiotherapy for endometrial cancer * No history of prior pelvic or abdominal radiotherapy Screening Exclusion Criteria: * Extrauterine disease, or gross lymph node involvement, or cervical invasion suspected on pre-operative imaging studies and physical examination (disease not uterine confined clinical stage \> I) * Contraindication for SLN mapping * The planned treatment is not surgery, or the surgical treatment does not include hysterectomy in combination with SLN biopsy and a bilateral salpingo-oophorectomy Eligibility Inclusion Criteria Patients will be classified in the study cohort (part 2; n=182) according to surgical treatment received, final post hysterectomy and staging pathologic report, and planned adjuvant treatment. The inclusion criteria are specified below. Study Cohort (n=182) A patient will be enrolled in the study cohort if all the following criteria are met: * At surgery, the patient must undergo: * Hysterectomy * Bilateral salpingo-oophorectomy, unless already performed (including allowing unilateral salpingo-oophorectomy if unilateral salpingo-oophorectomy already performed) * Bilateral pelvic SLN mapping (bilateral sentinel nodes are negative for malignancy) * On the final pathologic report, the patient must have a diagnosis of: * Stage I intermediate-risk endometrial endometrioid cancer (Grade 1 or Grade 2 with ≥ 50% myometrial invasion or Grade 3 with \<50% myometrial invasion, including non-invasive disease) * Negative pelvic peritoneal cytology * Adjuvant treatment as recommended by the multidisciplinary team must be as follows: * No adjuvant treatment, or * Intravaginal radiation only Eligibility Exclusion Criteria * There is intra-operative detection of extra-uterine disease or grossly involved lymph nodes * Presence of any positive pelvic nodes including micrometastasis and isolated tumor cells (ITC) * Hysterectomy is not performed * Bilateral salpingo-oophorectomy is not performed, unless already performed (unilateral salpingo-oophorectomy is allowed if unilateral salpingo-oophorectomy already performed) * Failed unilateral or bilateral SLN mapping * Patient undergoes a complete unilateral or bilateral pelvic lymphadenectomy * Patient undergoes a radical type C hysterectomy * Stage IA endometrioid cancer Grade1 or 2 and myometrial invasion \<50% * Stage IB Grade 3 endometrioid cancer * Non-endometrioid histology: Serous, clear cell, carcinosarcoma, undifferentiated, or de-differentiated histology noted on final hysterectomy pathology * Empty unilateral or bilateral sentinel lymph nodal packet(s) * Positive peritoneal cytology
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
16 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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ADVENTHEALTH (Data collection only)
RECRUITINGOrlando, Florida, 32804, United States
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Charles University and General University Hospital (Data Collection Only)
TERMINATEDPrague, Czechia
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Hartford Healthcare Cancer Institute @ Hartford Hospital
RECRUITINGHartford, Connecticut, 06102, United States
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Houston Methodist Cancer Center (Data Collection Only)
RECRUITINGHouston, Texas, 77030, United States
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L'Azienda Sanitaria Universitaria Friuli Centrale
RECRUITINGUdine, Italy
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Lehigh Valley Health Network
RECRUITINGAllentown, Pennsylvania, 18103, United States
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Mayo Clinic (Data Collection and Data Analysis)
ACTIVE_NOT_RECRUITINGRochester, Minnesota, 55905, United States
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Memorial Sloan Kettering Basking Ridge (All protocol activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (All protocol activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Commack (All Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (All protocol activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (All protocol activities)
RECRUITINGRockville Centre, New York, 11553, United States
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Memorial Sloan Kettering Westchester (All protocol activities)
RECRUITINGHarrison, New York, 10604, United States
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Miami Cancer Institute Baptist Health South Florida
RECRUITINGMiami, Florida, 33143, United States
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OSLO UNIVERSITY HOSPITAL,RIKSHOPITALET (Data Collection Only)
NOT_YET_RECRUITINGOslo, Norway
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OSPEDALE MICHELE E PIETRO (Data Collection Only)
RECRUITINGFerrera, Italy
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Sulaiman Al Habib Medical Group
NOT_YET_RECRUITINGKhobar, Eastern Province, Saudi Arabia
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