A Prospective, Single-center, Clinical Trial to Evaluate the Efficacy of Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors (Seminoma/Nonseminoma)(PITERLAND).

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 evaluate relapse-free survival during the first two years after SLNB. * To estimate the percentage of patients who did not require adjuvant treatment after primary endoscopic SLNB. * Determine the microRNA expression profile in blood plasma, evaluate miRNAs as a potential prognostic and predictive factor in patients with testicular germ cell tumors. * Assess the correlation between computed tomography and positive lymph nodes on examination. Participants will undergo: * surgical treatment including orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye. * 24 hours before the procedure, a radiopharmaceutical (RP) is injected into the spermatic cord, followed by SPECT to determine the regional sentinel lymph node(s). * The level of microRNA will be examined before surgery and 10 days after surgery.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
Federal State Budgetary Institute N.N. Petrov National Medical Research Center of Oncology Ministry of Health of the Russian Federation
RECRUITING
Saint Petersburg
Time Frame
Start Date: 2023-11-08
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 44
Treatments
Experimental: SLNB
Related Therapeutic Areas
Sponsors
Leads: N.N. Petrov National Medical Research Center of Oncology

This content was sourced from clinicaltrials.gov

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