Twenty Years' Experience in Retroperitoneal Lymph Node Dissection for Testicular Cancer in a Tertiary Referral Center

NCT06806917 | Recruiting

• 1 other identifier: RPLND-2021
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to evaluate the oncologic and functional outcomes of RPLND as primary treatment (stage I and IIA-IIB with negative markers) or of residual masses after chemotherapy (PC-RPLND) in the treatment of patients with seminomatous and non-seminomatous. In order to evaluate the role and the͛clinical impact of different surgical techniques of RPLND will be included patients treated with open, laparoscopic, and robot-assisted techniques

Conditions

Testicular Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS) and Recurrence-Free Survival (RFS)

  To evaluate oncological outcomes, namely Overall Survival (OS) and Recurrence-Free Survival (RFS), of O-RPLND

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Intraoperative and postoperative complications

  up to 3 months

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Phase 1 prospective Patients selected for the prospective phase will undergo open, laparoscopic, or robotic according to the usual care pathway; follow-up visits will follow the normal clinic practice. Retrospective phase 2 Patients selected for the retrospective phase underwent open, laparoscopic, or robotic according to the normal course of care from January 2000 to December 2020 and have already been undergone follow-up postoperative examinations and examinations according to normal clinical practice with follow-up up of 5 years.

You may qualify if:

• 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

You may not qualify if:

• Patient with comorbidities with contraindication to surgery
• Hemorrhagic diathesis

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (2)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

UO di Chirurgia Urologica della Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, Italy, Italy

RECRUITING

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Eugenio Brunocilla, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelo Mottaran, MD

CONTACT

+39 3398946529; angelo.mottaran2@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: February 4, 2025
• Study Start: December 1, 2021
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2031
• Last Updated: February 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)