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

NCT ID: NCT06806917

Last Updated: 2025-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2031-10-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Testicular Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eugenio Brunocilla, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status RECRUITING

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

Milan, Italy, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Angelo Mottaran, MD

Role: CONTACT

+39 3398946529

Facility Contacts

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Angelo Mottaran

Role: primary

+39 3398946529

Roberto Salvioni, MD

Role: primary

Other Identifiers

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RPLND-2021

Identifier Type: -

Identifier Source: org_study_id

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