Bladder TumorMSUTNCT04310813
Microscopic-spectroscopic Examination for Urothelial Tissue Characterization
An observational study of Bladder Tumor, run by Careggi Hospital.
Trial summary
To evaluate the possibility to properly discriminate between healthy bladder tissue and BCa with a multimodal fiber optic spectroscopy (MFOS) technique, in order to possibly introduce a more objective way to detect BCa, thus reducing inter-observer variability and maybe to determine urothelial carcinoma stage and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Tumor
- What is being tested?
- Multimodal spectroscopic analysis
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 1 Mar 2020
- 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 are enrolled at hospitalization in our Urology Ward for surgical operation. Patients in surgical note for TURBT for bladder cancer or for Trans-Urethral Resection of Prostate (TURP) for Benign Prostatic Hyperplasia (BPH) are prospectively enrolled. Age, history of bladder cancer, smoke habit and anamnesis are recorded before surgery. During time of bladder or prostate resection, freshly excised cold cup biopsies of both bladder cancer or healthy bladder mucosa are taken and sent for inspection through label-free multimodal fiber optic spectroscopy (MFOS) within 30 minutes. Specimens are sent to standard histopathological analysis. MFOS data are then compared to current gold standard methodology in order to develop a classification algorithm based on the spectral information provided by each technique.
Who may be able to join
- willingness to participate,
- legal age,
- full capacity to sign informed consent
- eligibility for each surgical operation according to the best clinical practice and the urological guidelines
Who cannot join
- concomitant use of Hexaminolevulinate (Hexvix®)
- concomitant ongoing UTIs,
- concomitant bladder stone presence,
- recent catheterization or persistent bladder catheterization at time of surgery,
- concomitant presence of other pelvic cancer (both prostate, urethral, uterine),
- previous chemotherapy or radiotherapy of the pelvis,
- patient refusal at informed consent.
About this study
To evaluate the possibility to properly discriminate between healthy bladder tissue and BCa with a multimodal fiber optic spectroscopy (MFOS) technique, in order to possibly introduce a more objective way to detect BCa, thus reducing inter-observer variability and maybe to determine urothelial carcinoma stage and grade with a comparable accuracy, specificity and sensibility of the current gold standard histopathological analysis
Read the detailed description
Observational single center study on human biological samples to evaluate the possibility to discriminate between healthy and tumor tissue on urothelial bladder samples. Aim of the study is to provide a fast, reliable and label free aid/alternative to current histopathology
- Conditions
- Bladder Tumor
- Being tested
- Multimodal spectroscopic analysis
- Keywords
- Bladdder Cancer, Urothelial tumor, Pathology, Spectroscopy, BCa
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal spectroscopic analysisDiagnostic test
During time of bladder or prostate resection, freshly excised cold cup biopsies of both bladder cancer or healthy bladder mucosa were taken and sent for inspection through label-free multimodal fiber optic spectroscopy (MFOS) within 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic urologic patients | Patients with bladder cancer or benign prostate hyperplasia undergoing urologic endoscopic procedures. Receives: Diagnostic Test: Multimodal spectroscopic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic concordance
concordance in identifying healthy and tumor tissue between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
Measured: 30 minutes from resection
Secondary outcomes (2)
grading concordance
concordance in discriminating low vs high grade tumor between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
Measured: 30 minutes from resection
staging concordance
concordance in discriminating Ta vs T1 vs T2 tumors between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
Measured: 30 minutes from resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Nov 2016
- Primary completion1 Dec 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder TumorStudies 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Careggi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Villa, Careggi Hospital
- Investigators
- Simone Morselli, MD, Study chair, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310813
- Sponsor's protocol ID
- CEAVC 10325/2016
- Acronym
- MSUT
- Status last verified
- Mar 2020
- First submitted
- 13 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microscopic-spectroscopic Examination for Urothelial Tissue Characterization
- ClinicalTrials.gov ID
- NCT04310813
- Acronym / sponsor ID
- MSUT / CEAVC 10325/2016
- Conditions
- Bladder Tumor
- Keywords
- Bladdder Cancer, Urothelial tumor, Pathology, Spectroscopy, BCa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Careggi HospitalUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 17 Mar 2020 (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.
To evaluate the possibility to properly discriminate between healthy bladder tissue and BCa with a multimodal fiber optic spectroscopy (MFOS) technique, in order to possibly introduce a more objective way to detect BCa, thus reducing inter-observer variability and maybe to determine urothelial carcinoma stage and grade with a comparable accuracy, specificity and sensibility of the current gold standard histopathological analysis
Detailed description
Observational single center study on human biological samples to evaluate the possibility to discriminate between healthy and tumor tissue on urothelial bladder samples. Aim of the study is to provide a fast, reliable and label free aid/alternative to current histopathology
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic urologic patients | – | Diagnostic Test: Multimodal spectroscopic analysisPatients with bladder cancer or benign prostate hyperplasia undergoing urologic endoscopic procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are enrolled at hospitalization in our Urology Ward for surgical operation. Patients in surgical note for TURBT for bladder cancer or for Trans-Urethral Resection of Prostate (TURP) for Benign Prostatic Hyperplasia (BPH) are prospectively enrolled. Age, history of bladder cancer, smoke habit and anamnesis are recorded before surgery. During time of bladder or prostate resection, freshly excised cold cup biopsies of both bladder cancer or healthy bladder mucosa are taken and sent for inspection through label-free multimodal fiber optic spectroscopy (MFOS) within 30 minutes. Specimens are sent to standard histopathological analysis. MFOS data are then compared to current gold standard methodology in order to develop a classification algorithm based on the spectral information provided by each technique.
Key inclusion criteria (4 listed)
- willingness to participate,
- legal age,
- full capacity to sign informed consent
- eligibility for each surgical operation according to the best clinical practice and the urological guidelines
Key exclusion criteria (7 listed)
- concomitant use of Hexaminolevulinate (Hexvix®)
- concomitant ongoing UTIs,
- concomitant bladder stone presence,
- recent catheterization or persistent bladder catheterization at time of surgery,
- concomitant presence of other pelvic cancer (both prostate, urethral, uterine),
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 |
|---|---|---|
| Multimodal spectroscopic analysisDuring time of bladder or prostate resection, freshly excised cold cup biopsies of both bladder cancer or healthy bladder mucosa were taken and sent for inspection through label-free multimodal fiber optic spectroscopy (MFOS) within 30 minutes | Diagnostic test | Endoscopic urologic patients |
Primary outcome
diagnostic concordance
Time frame: 30 minutes from resection
concordance in identifying healthy and tumor tissue between multimodal fiberoptic spectroscopy and pathology, considered as gold standard
2 secondary outcomes
grading concordance
Time frame: 30 minutes from resection
staging concordance
Time frame: 30 minutes from resection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- 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.
Simone Morselli, MD study chair
University of Florence
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Tumor, run by Careggi Hospital.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic concordance (time frame: 30 minutes from resection). 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 18 Mar 2020.