Comparing two methods for lymph node evaluation in early stage endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of sentinel lymph node mapping versus routine lymph node dissection in patients with early stage endometrial cancer. The standard treatment involves total hysterectomy and lymph node dissection, but recent studies suggest that routine dissection may not improve survival rates and can lead to complications. By utilizing sentinel lymph node mapping, the study seeks to provide a less invasive alternative that could reduce complications and improve patient quality of life. Participants will be monitored for lymph node status using advanced imaging techniques and surgical methods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 20 \~ 80 years old female
2. histologically diagnosed endometrial cancer that has never been treated before.
3. histological type :endometrioid, mucinous, serous, clear cell, uindifferentiated, dedifferentiated, mesonephric adenocarcinoma, mesonephric-like adenocarcinoma, carcinosarcoma, and mixed type
4. histological grade : FIGO grade 1, 2, 3
5. Presumed FIGO stage I-II
6. Planed for laparoscopic or robotic hystererctomy and lymph adenectomy
7. Largest pelvic or para-aortic lymph node diameter = or \< 15 mm in short axis on MRI
8. ECOG performance status 0-2
9. ASA PS 0-2
10. WBC ≥ 3,000/mm3, Platelets ≥ 100,000/mm3, Creatinine ≤ 2.0 mg/dL ,Bilirubin ≤ 1.5 x institutional upper limit normal ,SGOT, SGPT, and ALP ≤ 3 x institutional upper limit normal
11. A patient who voluntarily signed a document for the study.

Exclusion Criteria:

1. Presumed FIGO stage III-IV
2. Neuroendocrine tumor histology
3. Other disease involving lymphatic system
4. lymphedema of the lower extremity or inguinal area
5. previous pelvic or paraaortic lymph node dissection
6. previous radiation or concurrent chemoradiation therapy of abdomen or pelvis
7. previous chemotherapy due to malignant disease of abdomen or pelvis
8. Patients who have had or have been treated for cancer within five years, other than non-melanoma skin cancer, carcinoma in situ of uterine cervix, stomach or bladder
9. severe, uncontrolled underlying diseases or underlying disease with complications
10. hypersensitivity to indocyanine green
11. a pregnant or breast-feeding woman

Where it's running

• Asan Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Jeong-Yeol Park, M.D Ph.D.,
• Email: obgyjypark@amc.seoul.kr
• Phone: +82-2-3010-3646

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Personalized navigation to support rural and Black women with endometrial cancer

  This pilot tests a tailored patient-navigation program to help rural and Black patients with endometrial cancer access care and services.

  Recruiting UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT07927244

• CR-002 study in adults with advanced solid tumors

  This trial tests CR-002 as a single therapy to see if it is safe and tolerable in adults with locally advanced or metastatic solid tumors

  Recruiting at 3 sites Phase 1/2 Crescent Biopharma, Inc. · Austin, Texas and 2 other locations · NCT07909031

• Methylation markers in self-samples to help detect gynecological cancers

  This study tests whether self-collected urine and vaginal samples can reveal DNA methylation or other genetic markers that indicate endometrial, ovarian, vulvar, or vaginal cancers in women who are at risk or have postmenopausal bleeding.

  Recruiting Universiteit Antwerpen · Edegem, Antwerp · NCT07902375

• One-Finger Technique to identify the left upper ureter during para-aortic lymphadenectomy

  This study tests a new surgical method to help surgeons find the left upper ureter during open para-aortic lymphadenectomy in women with gynecologic cancers.

  Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07895212

• Liquid biopsy screening for early endometrial cancer in regional China

  A non-invasive blood test using cell-free DNA is being tested to see if it can detect early endometrial cancer and tell apart benign from malignant uterine lesions.

  Recruiting Guizhou Provincial People's Hospital · Guiyang, Guizhou · NCT07892755

• Radiotherapy for gynecologic cancer with up to 10 metastatic sites

  This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.

  Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość · NCT07883798

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.