Could a simpler lymph node check replace major surgery for endometrial cancer?
NCT ID NCT04276532
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two surgical approaches for women with middle-to-high risk endometrial cancer that hasn't spread beyond the uterus. One group gets sentinel lymph node sampling (removing only a few key nodes), while the other gets standard pelvic lymphadenectomy (removing many nodes). The goal is to see if the less invasive method is just as good at preventing cancer from coming back, while causing fewer side effects. About 780 women are taking part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 780 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 2030
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.
- Ages
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18 to 80 years
- 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.
Inclusion Criteria: 1. Older than 18 years old; 2. Clinically diagnosed (by pre-surgical pathology and radiology) as primary endometrial cancer confined to uterus with middle-high risk factors: 1. disease limited to the uterus on image study (MRI, CT or ultrasound); 2. including all histological types of endometrial cancer (endometrioid, serous, clear cell, carcinosarcoma, and undifferentiated carcinoma); not including uterine sarcoma 3. excluding low-risk endometrial cancer (endometrioid G 1-2 with pre-surgical endometrial lesion≤2cm and myometrial invasion \<50%); 4. with one or more middle-high risk factors including: endometrioid endometrial cancer G3, myometrial invasion ≥50%, tumor size≥2cm, type II endometrial cancer, molecular classification of p53abn, LVSI; 5. diagnosis should be confirmed by at least two senior clinicians; 3. Be able to undergo staging surgery. Exclusion Criteria: 1. During pregnancy or perinatal period; 2. With synchronous malignancies or other malignancies than endometrial cancer in 3 years, except for non-melanoma skin cancer; 3. With history of important organs transplantation; 4. With immune diseases requiring taking immunosuppressants 5. With severe mental illness or brain function disorders 6. With history of drug abuse; 7. Allergic to contrast agent; 8. Still participating in other clinical trials; 9. Not willing to accept surgery or trial protocol; 10. Not eligible for surgery; 11. Had hysterectomy, chemotherapy, radiotherapy, or hormone therapy before the trail; 12. Had retroperitoneum lymph node dissection for other reasons.
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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.
Contacts and locations
Locations
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Tenth People's Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, 200072, China
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Other studies related to the condition(s) this trial covers.
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