Urologic DiseasesNCT06187870
Bank of Biological Material From Patients and Healthy Donors for the Study of Urological and Uro-oncological Pathologies
An observational study of Urologic Diseases and Urologic Cancer, run by IRCCS San Raffaele at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urologic Diseases, Urologic Cancer, Infertility
- What is being tested?
- Collection of biological data
- How many people
- 15,000 participants
- Where
- 1 siteItaly
- Study dates
- 7 Oct 2010to 6 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with urological or uro-oncological diseases and infertility
Who may be able to join
- Male and female patients with an age > 18
- Ability to read and sign the informed consent
- patients affected by urological or uro-oncological diseases
Who cannot join
- People with an age < 18
- Incapacity to read and sign the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132
Andrea Salonia, MD, 02 2643 5661, salonia.andrea@hsr.it
About this study
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
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.
Read the 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.
- Conditions
- Urologic Diseases, Urologic Cancer, Infertility
- Being tested
- Collection of biological data
- Medical subject headings
- Urologic Diseases, Urologic Neoplasms, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological dataOther
Biological samples will be collected from the patient at the time of their access to the Hospital
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological sample
A biobank is a facility aimed at the collection, management, preservation and distribution of biomaterials and related data for research purposes
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start7 Oct 2010
- Primary completion6 Oct 2030 (estimated)
- Study completion6 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Salonia, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187870
- Sponsor's protocol ID
- URBBAN
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06187870
- Acronym / sponsor ID
- URBBAN
- Conditions
- Urologic Diseases, Urologic Cancer, Infertility
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 7 Oct 2010 (actual)
- Primary completion
- 6 Oct 2030 (estimated)
- Study completion
- 6 Oct 2030 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with urological or uro-oncological diseases and infertility
Key inclusion criteria (3 listed)
- Male and female patients with an age > 18
- Ability to read and sign the informed consent
- patients affected by urological or uro-oncological diseases
Key exclusion criteria (2 listed)
- People with an age < 18
- Incapacity to read and sign the informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of biological dataBiological samples will be collected from the patient at the time of their access to the Hospital | Other | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Diseases and Urologic Cancer, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Maria Ferrara (0226437795, ferrara.annamaria@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biological sample (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.