Bladder Tumor
Conditions
Keywords
Bladdder Cancer, Urothelial tumor, Pathology, Spectroscopy, BCa
Brief 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 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
Interventions
DIAGNOSTIC_TESTMultimodal spectroscopic analysis
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
Sponsors
Careggi Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic concordance | 30 minutes from resection | concordance in identifying healthy and tumor tissue between multimodal fiberoptic spectroscopy and pathology, considered as gold standard |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| grading concordance | 30 minutes from resection | concordance in discriminating low vs high grade tumor between multimodal fiberoptic spectroscopy and pathology, considered as gold standard |
| staging concordance | 30 minutes from resection | concordance in discriminating Ta vs T1 vs T2 tumors between multimodal fiberoptic spectroscopy and pathology, considered as gold standard |
Outcome results
None listed