Urothelial CarcinomaNCT04770974
Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic
An observational study of Urothelial Carcinoma and Bladder Cancer, run by University of Florence at 1 site in Italy.
Trial summary
Our multicenter observational study is a non-profit prospective study. The study was born from the Amplitude Project, which comprise the SOD of Minimally Invasive Robotic Urological Surgery and Renal Transplants of AOU Careggi with the University of Florence, as well as with the National Research Council (CNR) and the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma, Bladder Cancer, Urothelial Neoplasm
- What is being tested?
- Biomarkers and proteomics
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2020to 7 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will undergo a surgical intervention for bladder cancer will be enrolled
Who may be able to join
- Age>18 years
- Bladder Cancer diagnosis
- Capability to express informed consent
Who cannot join
- Age under 18
- Pregnancy
- Lack of informed consent
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Silvia Benemei, MD contact
Italy1 site, 1 recruiting
- Recruiting
Careggi Hospital
Florence, Tuscany, 50134
Simone Morselli, 3473050852, simone.morselli@unifi.it
Sergio Serni, Prof
About this study
Official title: Definition of Tumor Bio-markers and Physical-spectroscopic Differences Between Healthy Urothelial Tissue Healthy and Urothelial Cancer
Our multicenter observational study is a non-profit prospective study. The study was born from the Amplitude Project, which comprise the SOD of Minimally Invasive Robotic Urological Surgery and Renal Transplants of AOU Careggi with the University of Florence, as well as with the National Research Council (CNR) and the University of Milan Bicocca (UNIMIB) The study consists of a phase of enrollment of patients who will be admitted to the SOD of Mini Invasive Robotic Urological Surgery and Renal Transplantation of AOU Careggi. Enrollment in the study does not alter normal clinical practice and does not involve additional risks for patients. Patients will have to meet the inclusion and exclusion criteria of the study and will be enrolled sequentially, until the established sample size is reached. Patients undergoing surgery for the removal of bladder neoplasm, be it endoscopic or surgical with radical intent (cystectomy), will be taken a fragment of tumor bladder tissue, on which histopathological analysis will be performed. In patients undergoing radical cystectomy only, a fragment of healthy urothelial tissue, free from neoplasia, will also be removed. The samples will be performed in patients under general and / or spinal anesthesia in case of TURB, thus not causing pain or discomfort to the patient, or ex-vivo on the operative piece in case of radical cystectomy, without causing further damage or pain to the patient. From these samples, specially stored in solutions that keep their characteristics unaltered, a 3D culture model (organoid) will be obtained both from cells obtained from bladder cancer and from healthy tissue on which biomolecular, metabolomic and spectroscopic characterization studies will be tested and carried out. with a view to staging and grading bladder neoplasia.
- Conditions
- Urothelial Carcinoma, Bladder Cancer, Urothelial Neoplasm, Urothelial Carcinoma Bladder, Urothelial Carcinoma in Situ
- Being tested
- Biomarkers and proteomics
- Keywords
- spectroscopy, bladder cancer, urothelial carcinoma, tumor biomarkers, metabolomic, proteomic
- Medical subject headings
- Carcinoma, Transitional Cell, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarkers and proteomicsOther
Biomolecular, proteomic, metabolomic and spectroscopy characterization of urothelial bladder neoplasia, on a 3D culture model (organoid) obtained from bladder tumor tissue
| Study group | Role | What they receive |
|---|---|---|
| Urothelial Carcinoma | Patients over the age of 18 known for urological interventions for the following pathologies will be considered for enrollment in the group of cases:
- Bladder cancer
The exclusion criteria will be:
* Age under 18
* Pregnancy
* Lack of informed consent
* Inability to provide informed consent
Patients included in the study, who meet the inclusion criteria, have an operative note for:
* Transurethral Resection of Bladder Neoplasia (TURBT)
* Radical Cystectomy for Bladder Neoplasia Receives: Other: Biomarkers and proteomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomic
Metabolomic characteristic of bladder cancer
Measured: Enrollment
Spectroscopy
Spectroscopical characteristic of bladder cancer
Measured: Enrollment
Secondary outcomes (4)
Progression
Comparison between different progression pattern among bladder cancer
Measured: Seven years
Response to treatments
Comparison between different treatment response pattern among bladder cancer
Measured: Seven years
Survival
Comparison between different survival outcomes among bladder cancer
Measured: Seven years
Transcriptomic
Transcriptomic characteristic of bladder cancer
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start10 Dec 2020
- Primary completion7 Dec 2022 (estimated)
- Study completion7 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Careggi Hospital
- Responsible party
- Principal investigator, Simone Morselli, University of Florence
- Investigators
- Sergio Serni, Prof, Principal investigator, University of FlorenceMauro Gacci, MD, Principal investigator, AOU Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770974
- Sponsor's protocol ID
- 17852_bio
- Status last verified
- May 2022
- First submitted
- 22 Feb 2021
- Last updated
- 9 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baria E, Morselli S, Anand S, Fantechi R, Nesi G, Gacci M, Carini M, Serni S, Cicchi R, Pavone FS. Label-free grading and staging of urothelial carcinoma through multimodal fibre-probe spectroscopy. J Biophotonics. 2019 Nov;12(11):e201900087. doi: 10.1002/jbio.201900087. Epub 2019 Aug 13.
PubMed 31343832
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition of Tumor Bio-markers and Physical-spectroscopic Differences Between Healthy Urothelial Tissue Healthy and Urothelial Cancer
- ClinicalTrials.gov ID
- NCT04770974
- Acronym / sponsor ID
- 17852_bio
- Conditions
- Urothelial Carcinoma, Bladder Cancer, Urothelial Neoplasm, Urothelial Carcinoma Bladder, Urothelial Carcinoma in Situ
- Keywords
- spectroscopy, bladder cancer, urothelial carcinoma, tumor biomarkers, metabolomic, proteomic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- University of Milano Bicocca, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy, Careggi Hospital
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 7 Dec 2022 (estimated)
- Study completion
- 7 Dec 2022 (estimated)
- First posted
- 25 Feb 2021 (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.
Our multicenter observational study is a non-profit prospective study. The study was born from the Amplitude Project, which comprise the SOD of Minimally Invasive Robotic Urological Surgery and Renal Transplants of AOU Careggi with the University of Florence, as well as with the National Research Council (CNR) and the University of Milan Bicocca (UNIMIB) The study consists of a phase of enrollment of patients who will be admitted to the SOD of Mini Invasive Robotic Urological Surgery and Renal Transplantation of AOU Careggi. Enrollment in the study does not alter normal clinical practice and does not involve additional risks for patients. Patients will have to meet the inclusion and exclusion criteria of the study and will be enrolled sequentially, until the established sample size is reached. Patients undergoing surgery for the removal of bladder neoplasm, be it endoscopic or surgical with radical intent (cystectomy), will be taken a fragment of tumor bladder tissue, on which histopathological analysis will be performed. In patients undergoing radical cystectomy only, a fragment of healthy urothelial tissue, free from neoplasia, will also be removed. The samples will be performed in patients under general and / or spinal anesthesia in case of TURB, thus not causing pain or discomfort to the patient, or ex-vivo on the operative piece in case of radical cystectomy, without causing further damage or pain to the patient. From these samples, specially stored in solutions that keep their characteristics unaltered, a 3D culture model (organoid) will be obtained both from cells obtained from bladder cancer and from healthy tissue on which biomolecular, metabolomic and spectroscopic characterization studies will be tested and carried out. with a view to staging and grading bladder neoplasia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urothelial Carcinoma | – | Other: Biomarkers and proteomicsPatients over the age of 18 known for urological interventions for the following pathologies will be considered for enrollment in the group of cases: - Bladder cancer The exclusion criteria will be: * Age under 18 * Pregnancy * Lack of informed consent * Inability to provide informed consent Patients included in the study, who meet the inclusion criteria, have an operative note for: * Transurethral Resection of Bladder Neoplasia (TURBT) * Radical Cystectomy for Bladder Neoplasia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will undergo a surgical intervention for bladder cancer will be enrolled
Key inclusion criteria (3 listed)
- Age>18 years
- Bladder Cancer diagnosis
- Capability to express informed consent
Key exclusion criteria (4 listed)
- Age under 18
- Pregnancy
- Lack of informed consent
- Inability to provide 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 |
|---|---|---|
| Biomarkers and proteomicsBiomolecular, proteomic, metabolomic and spectroscopy characterization of urothelial bladder neoplasia, on a 3D culture model (organoid) obtained from bladder tumor tissue | Other | Urothelial Carcinoma |
Primary outcome
Metabolomic
Time frame: Enrollment
Metabolomic characteristic of bladder cancer
Spectroscopy
Time frame: Enrollment
Spectroscopical characteristic of bladder cancer
4 secondary outcomes
Progression
Time frame: Seven years
Response to treatments
Time frame: Seven years
Survival
Time frame: Seven years
Transcriptomic
Time frame: Enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Background: PubMed 31343832Baria E, Morselli S, Anand S, Fantechi R, Nesi G, Gacci M, Carini M, Serni S, Cicchi R, Pavone FS. Label-free grading and staging of urothelial carcinoma through multimodal fibre-probe spectroscopy. J Biophotonics. 2019 Nov;12(11):e201900087. doi: 10.1002/jbio.201900087. Epub 2019 Aug 13.
- Related InfoLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Silvia Benemei, MD contact
Sergio Serni, Prof principal investigator
University of Florence
Mauro Gacci, MD principal investigator
AOU Careggi
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 Urothelial Carcinoma and Bladder Cancer, run by University of Florence 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 4 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: status not confirmed, as of the sponsor's last update on 9 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simone Morselli, MD (3473050852, simone.morselli@unifi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomic (time frame: Enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04770974, which also lists 1 linked publication.
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 9 May 2022.