Clinical trial NCT06187870: Bank of Biological Material From Patients and Healthy Donors for the Study of Urological and Uro-oncological Pathologies
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urologic Diseases
Urologic Cancer
Infertility
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with urological or uro-oncological diseases and infertility

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Biological sample
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardy
Study officials:
References: