Creation of a Biobank of Fertile Men

December 19, 2023 updated by: Andrea Salonia, IRCCS San Raffaele

Creation of a Biobank of Biological Samples From Fertile Men

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele Hospital
        • Contact:
          • Andrea Salonia, MD
          • Phone Number: +390226435661
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • IRCCS Ospedale San Raffaele
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Normospermic male individuals, naturally fertile men recruited on an outpatient and day-hospital basis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic role of the biological material
Time Frame: Baseline
Biological signature in fertile men predicting potential therapeutic, prognostic and diagnostic biomarkers
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2016

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

June 15, 2026

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Estimated)

January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Urimales-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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