Testicular CancerNCT06806917
Twenty Years' Experience in Retroperitoneal Lymph Node Dissection for Testicular Cancer in a Tertiary Referral Center
An observational study of Testicular Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Testicular Cancer
- How many people
- 65 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Dec 2021to 31 Oct 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Angelo Mottaran, +39 3398946529, angelo.mottaran2@unibo.it
- Recruiting
UO di Chirurgia Urologica della Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Italy
Roberto Salvioni, MD, roberto.salvioni@istitutotumori.mi.it
About this study
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
Read the detailed 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
- Conditions
- Testicular Cancer
- Medical subject headings
- Testicular Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) and Recurrence-Free Survival (RFS)
To evaluate oncological outcomes, namely Overall Survival (OS) and Recurrence-Free Survival (RFS), of O-RPLND
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Intraoperative and postoperative complications
To describe intraoperative and postoperative complications, including ejaculatory disorders.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Dec 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugenio Brunocilla, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806917
- Sponsor's protocol ID
- RPLND-2021
- Status last verified
- Dec 2024
- First submitted
- 10 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twenty Years' Experience in Retroperitoneal Lymph Node Dissection for Testicular Cancer in a Tertiary Referral Center
- ClinicalTrials.gov ID
- NCT06806917
- Acronym / sponsor ID
- RPLND-2021
- Conditions
- Testicular Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2031 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival (OS) and Recurrence-Free Survival (RFS)
Time frame: through study completion, an average of 1 year
To evaluate oncological outcomes, namely Overall Survival (OS) and Recurrence-Free Survival (RFS), of O-RPLND
1 secondary outcome
Intraoperative and postoperative complications
Time frame: up to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eugenio Brunocilla, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelo Mottaran, MD (+39 3398946529, angelo.mottaran2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) and Recurrence-Free Survival (RFS) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.