Evaluating sentinel lymph node biopsy for early-stage testicular cancer
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).
This study is testing if a special lymph node biopsy can help men with early-stage testicular cancer avoid relapse and extra treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | N.N. Petrov National Medical Research Center of Oncology Academic / other |
| Locations | 1 site (Saint-Petersburg) |
| Trial ID | NCT06133699 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of sentinel lymph node biopsy (SLNB) in patients with stage AI-IIA germ cell tumors, including both seminoma and non-seminoma types. Participants will undergo orchofuniculectomy along with a laparoscopic biopsy of the sentinel lymph node using indocyanine green dye, with the goal of determining relapse-free survival and the need for adjuvant treatment. Additionally, the study will explore the prognostic value of microRNA profiles in blood plasma as potential predictive factors for treatment outcomes. The trial will recruit 44 male patients diagnosed with testicular tumors and will utilize advanced imaging techniques for preoperative planning.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older with a provisional diagnosis of testicular tumor and isolated retroperitoneal lymphadenopathy.
Not a fit: Patients with severe uncontrolled chronic diseases, poor general condition, or elevated tumor markers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the need for adjuvant treatment in patients with early-stage testicular cancer, leading to better quality of life and fewer side effects.
How similar studies have performed: While the use of SLNB in testicular cancer is a novel approach, similar studies in other cancers have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Saint-Petersburg
- Federal State Budgetary Institute N.N. Petrov National Medical Research Center of Oncology Ministry of Health of the Russian Federation — Saint-Petersburg, Russian Federation (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.