Status:
ACTIVE_NOT_RECRUITING
Sentinel Lymph Node Sampling for Patients With Middle-high Risk Endometrial Cancer Confined to the Uterus
Lead Sponsor:
Xiaojun Chen
Collaborating Sponsors:
Fudan University
Tongji Hospital
Conditions:
Middle-high Risk Endometrial Cancer
Sentinel Lymph Node Sampling
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief 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.
Detailed Description
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. Rationale Th...
Eligibility Criteria
Inclusion
- Older than 18 years old;
- Clinically diagnosed (by pre-surgical pathology and radiology) as primary endometrial cancer confined to uterus with middle-high risk factors:
- Disease limited to the uterus on image study (MRI, CT or ultrasound);
- including all histological types of endometrial cancer (endometrioid, serous, clear cell, carcinosarcoma, and undifferentiated carcinoma); not including uterine sarcoma
- excluding low-risk endometrial cancer (endometrioid G 1-2 with pre-surgical endometrial lesion≤2cm and myometrial invasion \<50%);
- with one or more middle-high risk factors including: endometrioid endometrial cancer G3, myometrial invasion ≥50%, tumor size≥2cm, type II endometrial cancer; LVSI
- diagnosis should be confirmed by at least two senior clinicians.
- Be able to undergo staging surgery.
Exclusion
- During pregnancy or perinatal period;
- With malignancies other than endometrial cancer;
- With history of important organs transplantation;
- With immune diseases requiring taking immunosuppressants
- With severe mental illness or brain function disorders
- With history of drug abuse;
- Allergic to contrast agent;
- Still participating in other clinical trials;
- Not willing to accept surgery or trial protocol;
- Not eligible for surgery;
- Had hysterectomy, chemotherapy, radiotherapy, or hormone therapy before the trail;
- Had retroperitoneum lymph node dissection for other reasons.
Key Trial Info
Start Date :
February 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 12 2030
Estimated Enrollment :
780 Patients enrolled
Trial Details
Trial ID
NCT04276532
Start Date
February 13 2020
End Date
February 12 2030
Last Update
February 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200011