Clinical trial · Interventional
Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors
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).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Germ Cell Tumor | Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye. | Procedure | — | UNRESOLVED |
| Radiopharmaceutical administration (Technetium/methylene blue) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SLNB
- interventionNames
- Procedure: Orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye.
- Diagnostic Test: Radiopharmaceutical administration (Technetium/methylene blue)
Primary outcomes (4)
- measure
- Relapse-free survival during the first two years after SLNB
- timeFrame
- two years
- measure
- The percentage of patients who did not require adjuvant treatment after primary endoscopic SLNB
- timeFrame
- two years
- measure
- Evaluation of miRNAs as a potential prognostic and prognostic factor in patients with testicular germ cell tumors.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
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