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NCT04770974
Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic
trial testing Biomarkers and proteomics in Urothelial Carcinoma in 200 participants. Status unknown.
7 December 2022
Quick facts
| Lead sponsor | University of Florence |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 200 |
| Start date | 10 December 2020 |
| Primary completion | 7 December 2022 |
| Estimated completion | 7 December 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Biomarkers and proteomics
Conditions studied
- Urothelial Carcinoma — all drugs for Urothelial Carcinoma →
- Bladder Cancer — all drugs for Bladder Cancer →
- Urothelial Neoplasm — all drugs for Urothelial Neoplasm →
- Urothelial Carcinoma Bladder — all drugs for Urothelial Carcinoma Bladder →
Sponsor
University of Florence
Who can join
18 and older, any sex, with Urothelial Carcinoma or Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Preclinical and Clinical Applications of Metabolomics and Proteomics in Glioblastoma Research.
Ahmed M, Semreen AM, El-Huneidi W, Bustanji Y, et al · · 2022 · cited 16× · PMID 36613792 · DOI 10.3390/ijms24010348
Verify or expand the search:
- PubMed search for NCT04770974
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04770974 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Florence
- Last refreshed: 9 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04770974.
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