Evaluating surgical outcomes for testicular cancer treatment
Twenty Years' Experience in Retroperitoneal Lymph Node Dissection for Testicular Cancer in a Tertiary Referral Center
This study is testing different surgical methods for treating testicular cancer to see how well they work and how they affect patients' lives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 65 (estimated) |
| Sex | Male |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Bologna, Bologna and 1 other locations) |
| Trial ID | NCT06806917 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the oncologic and functional outcomes of retroperitoneal lymph node dissection (RPLND) in patients with testicular cancer, focusing on both primary treatment and treatment of residual masses after chemotherapy. It includes a multicenter prospective observational phase where patients undergo RPLND using open, laparoscopic, or robot-assisted techniques, as well as a retrospective phase analyzing data from patients treated between 2000 and 2020. The study will follow patients for five years to evaluate the effectiveness of these surgical approaches.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with seminomatous or non-seminomatous testicular neoplasms requiring RPLND.
Not a fit: Patients with significant comorbidities that contraindicate surgery or those with hemorrhagic diathesis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies and outcomes for patients with testicular cancer.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥ 18 years * RPLND of residual mass after chemotherapy in patient with testicular neoplasm seminomatous or nonseminomatous performed by open, laparoscopic, or robotic technique * Primary RPLND for seminomatous or nonseminomatous testicular neoplasm of stage I or IIA-IIB with negative markers performed with open, laparoscopic or robotic technique * RPLND performed by open, laparoscopic, or robotic technique for the treatment of tumors seminomatous or nonseminomatous chemiorefractory testicular tumors progressing after I and II line of chemotherapy * Acquisition of informed consent Exclusion criteria: * Patient with comorbidities with contraindication to surgery * Hemorrhagic diathesis RETROSPECTIVE PHASE. Patients with the same inclusion and exclusion criteria as in the prospective phase and already undergoing RPLND surgery with open, laparoscopic, or robotic technique from January 2000 to December 2020 in the͛framework of the normal course of care with a minimum follow-up of 12 months. (estimated to include approximately 120 patients).
Where this trial is running
Bologna, Bologna and 1 other locations
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
- UO di Chirurgia Urologica della Fondazione IRCCS Istituto Nazionale dei Tumori di Milano — Milan, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Eugenio Brunocilla, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Angelo Mottaran, MD
- Email: angelo.mottaran2@unibo.it
- Phone: +39 3398946529
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.