Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors

Launched by N.N. PETROV NATIONAL MEDICAL RESEARCH CENTER OF ONCOLOGY · Nov 10, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a procedure called sentinel lymph node biopsy (SLNB) for men with early-stage testicular germ cell tumors. The main goals are to see how well this biopsy helps prevent cancer from coming back in the first two years, how many patients can avoid extra treatments after the biopsy, and to study certain markers in the blood that might help predict outcomes for patients. Participants will have a small surgery to remove a testicle and a biopsy of nearby lymph nodes, using a special dye to help the doctors see where to look. Before the surgery, a small amount of a radioactive substance will be injected to identify the sentinel lymph node.

To be eligible for this study, participants need to be at least 18 years old and have a testicular tumor with lymph nodes that are swollen but isolated in the abdomen. Some health issues could disqualify someone, like serious chronic diseases or previous cancer treatments. Participants can expect careful monitoring of their health throughout the trial, including tests to check the levels of specific molecules in their blood before and after surgery. This trial is currently recruiting participants to better understand the potential benefits of this new approach to treating testicular cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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)