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Clinical Trials in China / NCT04276532
Active, not recruiting Not applicable

Sentinel Lymph Node Sampling for Patients With Middle-high Risk Endometrial Cancer Confined to the Uterus

NCT04276532 · tracked via the Priya Life Science China tracker
Sponsor
Xiaojun Chen
Phase
Not applicable
Started
2020-02-13
Last updated
2026-05-12

Condition(s) studied

Middle-high Risk Endometrial CancerSentinel Lymph Node SamplingPrognosis

Investigational drug(s) / intervention(s)

sentinel lymph node sampling (SLN)pelvic lymphonodectomy (PLN)

sentinel lymph node sampling (SLN): Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN). 1. The principles of surgery procedures and post-operative adjuvant therapies will follow the latest NCCN guidelines; 2. Surgery carried out by laparotomy, laparoscope, or robotic surgery are accepted; 3. Colored dyes including indocyanine green (ICG) (preferred), methylene blue, carbon nanotube for sentinel lymph node are accepted.

pelvic lymphonodectomy (PLN): Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with or without para-aortic sampling

Study summary

Aim To investigate the effect of sentinel lymph node (SLN) sampling on the prognosis of patients with middle-high risk endometrial cancer obviously confined to the uterus before surgery.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Tenth People's Hospital Affiliated to Tongji University Shanghai Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04276532 on ClinicalTrials.gov ↗ ← All trials in China