Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell 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

Biomolecular, proteomic, metabolomic and spectroscopy characterization of urothelial bladder neoplasia, on a 3D culture model (organoid) obtained from bladder tumor tissue

Biomarkers and proteomics

Simone Morselli, MD

Silvia Benemei, MD

Simone Morselli

Sergio Serni, Prof

Mauro Gacci, MD

Andrea Liaci, MD

Luca Gemma, MD

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.

Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic

Definition of Tumor Bio-markers and Physical-spectroscopic Differences Between Healthy Urothelial Tissue Healthy and Urothelial Cancer

Metabolomic characteristic of bladder cancer

Spectroscopical characteristic of bladder cancer

Comparison between different progression pattern among bladder cancer

Comparison between different treatment response pattern among bladder cancer

Comparison between different survival outcomes among bladder cancer

Transcriptomic characteristic of bladder cancer

University of Milano Bicocca

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Careggi Hospital

University of Florence

PhD Student

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Infective Agents

All Drugs and Chemicals

Herbal and Botanical

Formaldehyde

Cola

Secondary surgery is performed in patients with pejorative histopathologic feature(s) of the tumor.

Immunoscore Colon is an in-vitro diagnostic test, allowing the quantification of CD3 and CD8 positive cells in formalin-fixed paraffin-embedded (FFPE) tissue samples of primary colon cancer.

The test uses immunohistochemistry, digital pathology techniques and a dedicated image analysis software to determine CD3+ and CD8 + cell densities in the tumor ant in the invasive margin of the tumor.

Immunoscore Colon Test

Touria El Aamri

Yvann Frigout

Franck PAGÈS, MD

Franck Pagès, MD

The overall aim of this study is to determine whether the Immunoscore associated with histopathological features of endoscopically resected stage T1 colorectal tumors is predictive of locoregional lymph node invasion, in order to better select patients eligible for an organ preservation strategy.

The frequency of stage T1 superficial colorectal cancer (CRC) is around 15% and its incidence increases. In France, T1 superficial CCR is mostly treated with endoscopic submucosal dissection (ESD), offering potentially curative, organ-preserving treatment. The presence of pejorative histological criteria (eg. poor differentiation, budding, lymphovascular invasion), detected in about 50% of the tumors, leads to a secondary colectomy or rectal resection with postoperative complications and significant digestive, urological, and sexual functional sequelae. Strikingly, secondary surgical resection is performed in excess in 70 to 80% of the cases, given that no tumor is evidence in the colon and draining lymph nodes. Organ preservation (no secondary surgery) could be offered to a larger number of patients if biomarkers could complete the histological evaluation to better predict metastatic extension to lymph nodes.

Our team showed that the type, density, and location of immune cells in CRC strongly correlated with patients' survival at all disease stages. Our team created an "Immunoscore" (IS) assay, based on CD3+ and cytotoxic CD8+ T-cell densities determined by digital pathology in the tumor and its invasive margin. The robustness and prognostic performance of IS was validated in CRC . Sub-analysis of T1 tumors was not possible (only 31 cases) and tumor specimens did not result from endoscopic resection.

The objective of the study is to determine whether the Immunoscore associated with histopathological features of endoscopically resected stage T1 colorectal tumors is predictive of locoregional lymph node invasion, in order to better select patients eligible for an organ preservation strategy.

Personalized Medicine in Early Stage Colorectal Cancer: Organ Preservation and Immune Benefit

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol could be shared for the purpose of a metaanalysis.

Impact of Immunoscore stratification on lymph node invasion rate in patients with secondary surgery

Impact of Immunoscore stratification combined to Histological risk factors on lymph node invasion rate

Assessment of Immunological features measured by RNA sequencing on tumor samples.

Assessment of molecular profile of the tumor by transcriptomic profile measured by RNAseq. CMS classification will be determined

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Urothelial Cancer Tumor Bio-markers and Physical-spectroscopic Characteristic	NCT04770974	Urothelial Carc... Bladder Cancer Urothelial Neop... Urothelial Carc... Urothelial Carc...	Biomarkers and ...	18 Years -	University of Florence
Personalized Medicine in Early Stage Colorectal Cancer: Organ Preservation and Immune Benefit	NCT06251726	Colorectal Canc...	Immunoscore Col...	18 Years -	Assistance Publique - Hôpitaux de Paris

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