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NCT06189677 Clinical Trial

Creation of a Biobank of Fertile Men

Fertility Clinical Trial

Official title:
Creation of a Biobank of Biological Samples From Fertile Men

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06189677
Other study ID # Urimales-2016
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 16, 2016
Est. completion date June 15, 2026

Study information
Verified date December 2023
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Collection and conservation of human biological material from fertile subjects, i.e. men with previous parenthood (normospermic men, natural fathers).

Description:

The project aims to collect biological material derived both from surgical resections of the most common urological tumors and from peripheral blood or other biological fluids such as urine or seminal fluid when available. The objective of the study is to establish a biobank of human biological material, which will allow access to samples of extreme value for the pathophysiological study of the tumor, its origin, mechanisms and markers of progression, as well as the creation of this collection it will represent an extremely valuable tool for the study of individual response to therapies.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date June 15, 2026
Est. primary completion date June 15, 2024
Accepts healthy volunteers
Gender Male
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Normospermic male individuals - Naturally fertile male individuals - Male individuals > 18 years Exclusion Criteria: - Non-normospermic male individuals - Male individuals who are not naturally fertile - Male individuals < 18 years

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Observation of biological characteristics of fertile men
Sampling in outpatient settings, after biopsy or after surgery and collection of biological samples in fertile subjects

Locations
Country Name City State
Italy IRCCS Ospedale San Raffaele Milan Lombardy
Italy IRCCS San Raffaele Hospital Milan

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prognostic role of the biological material Biological signature in fertile men predicting potential therapeutic, prognostic and diagnostic biomarkers Baseline
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