Bank of Biological Material From Patients and Healthy Donors for the Study of Urological and Uro-oncological Pathologies

January 8, 2024 updated by: Andrea Salonia, IRCCS San Raffaele

Creation of a Bank of Biological Material From Patients and Healthy Donors (Biobank) for the Study of Urological and Uro-oncological Pathologies - URBBAN

The project aims to collect fresh biological material derived both from surgical resections performed in diseases, neoplastic and otherwise, of urological relevance at the level of the prostate, bladder, kidney, testicle and genitourinary organs, and from peripheral blood or other fluids biological samples such as urine, seminal fluid, buccal mucosa, feces or saliva, when available.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Significant studies have shown the great potential of research based on access to biobanks which has made it possible to conduct studies and obtain important results through retrospective studies carried out on samples collected some time ago. Thanks to the possibility of accessing human biological samples collected and stored in biological banks, great results have been achieved in the medical field. The project aims to collect fresh biological material deriving from surgical resections performed in neoplastic and non-neoplastic pathologies of urological relevance at the level of the prostate, bladder, kidney, testicle and genitourinary organs, both from biological samples of peripheral blood or other fluids such as urine, seminal fluid, buccal mucosa, feces or saliva, when available.

The possibility of obtaining biological samples from the patient at the time of the first visit or the first biopsy and, subsequently, in conjunction with a possible surgical intervention, could ideally give the possibility of studying the disease from its possible onset to the possible intervention, evaluating the evolution and possible association with circulating diagnostic and prognostic markers. The establishment of this collection of research material will allow access to samples of extreme value for the pathophysiological study of the disease, its origin, mechanisms and markers of progression. The data obtained can also be correlated with the patient's clinical history in order to build an overall vision potentially useful in the design of new therapeutic strategies.

Study Type

Observational

Enrollment (Estimated)

15000

Contacts and Locations

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

Study Contact

Study Locations

  • Italy
    • 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
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

People with urological or uro-oncological diseases and infertility

Description

Inclusion Criteria:

  • Male and female patients with an age > 18
  • Ability to read and sign the informed consent
  • patients affected by urological or uro-oncological diseases

Exclusion Criteria:

  • People with an age < 18
  • Incapacity to read and sign the informed consent

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
Biological sample
Time Frame: Baseline
A biobank is a facility aimed at the collection, management, preservation and distribution of biomaterials and related data for research purposes
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)

October 7, 2010

Primary Completion (Estimated)

October 6, 2030

Study Completion (Estimated)

October 6, 2030

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

December 28, 2023

First Posted (Actual)

January 3, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URBBAN

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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