Status:
UNKNOWN
Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors
Lead Sponsor:
N.N. Petrov National Medical Research Center of Oncology
Conditions:
Testicular Germ Cell Tumor
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the efficacy of sentinel lymph node biopsy in stage AI-IIA germ cell tumors (seminoma/nonseminoma). The main questions it aims to answer are: * To evalu...
Detailed Description
Research Design This study is a prospective, single-center, non-randomized study evaluating the role of primary endoscopic SLNB on progression-free survival in patients with stage I-II germ cell semin...
Eligibility Criteria
Inclusion
- Male person at least 18 years of age at the time of signing the informed consent form;
- Provisional diagnosis of testicular tumor with isolated retroperitoneal lymphadenopathy;
- Computed tomography data of the abdominal cavity and retroperitoneal space with axial visualization of lymphadenopathy (within 6 weeks before the planned date of surgical treatment): at least one lymph node larger than 1 cm.
Exclusion
- Severe or uncontrolled concomitant chronic diseases or acute diseases;
- Any condition that, in the opinion of the physician, may limit compliance with the study;
- Poor general condition (ECOG \> 2, KPS \< 70);
- Refusal of the patient to comply with the study procedures or refusal of the patient to continue participating in the study;
- Development of diseases or conditions that prevent the patient's continued participation in the study;
- AFP level is higher than reference values and / or b-hCG \> 100 mIU/ml;
- Presence of a second malignant disease;
- History of systemic antitumor therapy and/or radiotherapy;
- Inadequate bone marrow, liver, kidney function: (Neutrophils \< 1.5 x 10\^9/l, Platelets \< 100 x 10\^9/l, ALT \> 3 x ULN, AST \> 3 x ULN, Total bilirubin \> 1.5 xULN, GFR \<35 ml/min)
Key Trial Info
Start Date :
November 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06133699
Start Date
November 8 2023
End Date
November 30 2025
Last Update
January 3 2024
Active Locations (1)
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1
Federal State Budgetary Institute N.N. Petrov National Medical Research Center of Oncology Ministry of Health of the Russian Federation
Saint Petersburg, Russia, 197758