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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06187870
• Other study ID #: URBBAN
• Status: Recruiting
• Start date: October 7, 2010
• Est. completion date: October 6, 2030

Study information

• Verified date: December 2023
• Source: IRCCS San Raffaele
• Contact: Anna Maria Ferrara
• Phone: 0226437795
• Email: ferrara.annamaria[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: October 6, 2030
• Est. primary completion date: October 6, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Urologic Cancer
• Urologic Diseases
• Urologic Neoplasms

Intervention

Other:
• Collection of biological data
Biological samples will be collected from the patient at the time of their access to the Hospital

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological sample	A biobank is a facility aimed at the collection, management, preservation and distribution of biomaterials and related data for research purposes	Baseline