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

Last updated: January 28, 2025
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urologic Cancer

Testicular Cancer

Treatment

N/A

Clinical Study ID

NCT06806917
RPLND-2021
  • Male

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged ≥ 18 years

  • RPLND of residual mass after chemotherapy in patient with testicular neoplasmseminomatous or nonseminomatous performed by open, laparoscopic, or robotictechnique

  • Primary RPLND for seminomatous or nonseminomatous testicular neoplasm of stage I orIIA-IIB with negative markers performed with open, laparoscopic or robotic technique

  • RPLND performed by open, laparoscopic, or robotic technique for the treatment oftumors seminomatous or nonseminomatous chemiorefractory testicular tumorsprogressing after I and II line of chemotherapy

  • Acquisition of informed consent

Exclusion

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).

Study Design

Total Participants: 65
Study Start date:
December 01, 2021
Estimated Completion Date:
October 31, 2031

Study Description

The purpose of this study is to evaluate the oncologic and functional outcomes of RPLND as primary treatment or residual masses after chemotherapy in the treatment of patients with seminomatous and nonseminomatous tumors.

In order to evaluate the role and clinical impact of different surgical techniques of RPLND will be included patients treated with open, laparoscopic, and robot-assisted techniques.

The study will be divided into two phases (a prospective and a retrospective phase):

  • Phase 1 prospective is characterized by a multicenter prospective observational study international in which patients, competitively enrolled, undergo RPLND with open, laparoscopic or robot-assisted performed according to standard clinical practice from September 1, 2021 to October 31, 2026 and with 5-year follow-up.

  • Retrospective Phase 2 is characterized by a multicenter retrospective international study involving the selection of patients who have already undergone RPLND, from January 2000 to December 2020 with a minimum follow-up of 12 months and data available from medical records, institutional databases, outpatient referrals or follow-up phone calls

Connect with a study center

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138
    Italy

    Active - Recruiting

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

    Milano,
    Italy

    Active - Recruiting

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