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

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Infections

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Neoplasm Metastasis

Stomach Neoplasms

Breast Neoplasms

Triple Negative Breast Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Carcinoma, Renal Cell

Squamous Cell Carcinoma of Head and Neck

Sarcoma

Carcinoma, Merkel Cell

Neoplasms, Second Primary

Neoplasms, Squamous Cell

Adenocarcinoma

Breast Diseases

Skin Diseases

Neoplastic Processes

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Head and Neck Neoplasms

Stomach Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Soft Tissue Sarcoma

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antibodies

Immunoglobulins

Escalating doses of OC-001 administered intravenously (IV)

Doses of OC-001 administered by IV in combination anti-PD-1 or anti-PD-L1 Antibody (Ab)

OC-001

Anti-PD-1/anti-PD-L1 Ab administered per approved prescribing schedule, in Phase 2a

OC-001 in Combination

Study Director: Ocellaris Pharma, Inc

Quincy Chu

Derek Jonker

Amit Oza

Ivgenya Kosenko

Wilson Miller

Marie-Eve Rego

Diane Provencher

Ocellaris Pharma, Inc

This study will investigate OC-001 as monotherapy, and in combination with an anti-Programmed Cell Death Protein-1 (PD-1) or anti-Programmed Cell Death Ligand-1 (PD-L1) Antibody inhibitor, in various cancer types

A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers

A Phase 1b/2a Two-Part, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of OC-001 as Monotherapy and in Combination With an Anti-PD-1/Anti-PD-L1 Antibody in Patients With Selected Locally Advanced or Metastatic Cancers

A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the criteria identified in the Common Terminology Criteria for Adverse Events (CTCAE, Version 5)

Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a

After single and multiple dose administration

In combination with an anti-PD-1 or anti-PD-L1 antibody

Ocellaris Pharma, Inc.

Hematuria

Urination Disorders

Hemorrhage

In the ''care-as-usual'' arm, all patients undergo 'care-as-usual', i.e. a cystoscopy and upper tract imaging (ultrasound or CT-scan)

In the intervention arm, the urine test is used to triage patients for a diagnostic workup ('urine-first' strategy). Only patients with an abnormal test result undergo cystoscopy and upper tract imaging.

Only patients with an abnormal urine test result undergo a diagnostic workup, i.e. cystoscopy and upper-tract imaging.

urine-first strategy

J.L. Boormans, Prof. MD

O.M. Pijpers, MD

The SeARCH-trial assess the clinical impact of a molecular urine test as a 'urine-first' strategy in the diagnostic workup of patients presenting with microscopic hematuria.

Microscopic hematuria (MH) can be a sign of an underlying disease, including malignancy of the urinary tract, and is reason for referral to a urology clinic. The current standard diagnostic workup for MH patients includes visual inspection of the bladder by cystoscopy and upper tract imaging to rule out the presence of a tumor in the urinary tract. However, the a priori risk of cancer in patients with MH is only 2-5%. Consequently, 95% of MH patients unnecessarily undergo invasive procedures, which are: I) uncomfortable and stressful for patients, II) has a significant impact on limited available (financial) resources and III) a CT scan is accompanied by exposure to ionizing radiation.

Previously we developed a molecular urine assay to detect urinary tract cancer in hematuria patients that had robust diagnostic performance; a negative predictive value \>99%, sensitivity, and specificity \>90%. The SeARCH-trial evaluates the clinical impact of a urine assay as a 'urine-first' strategy, meaning that only patients with an abnormal urine test results undergo invasive diagnostics. In this multicenter stepped-wedge cluster randomized trial we compare clinical outcomes by using a 'urine-first' strategy to 'care-as-usual', which is a cystoscopy and upper tract imaging in all patients presenting with MH. In addition, we assess patients' preferences, patients reported outcome measurements, and healthcare costs to show that a 'urine-first' strategy improves patients' quality of life and results in a more appropriate use of limited available resources.

A multicenter, stepped wedge cluster randomized trial

This is a stepped wedge cluster randomized clinical trial

Safely Reduce Cystoscopic Evaluations for Hematuria Patients

The net benefit is defined as the proportion of patients who were diagnose with urinary tract cancer within 1 year after initial diagnostic work-up in the population (true positives) subtracted by the proportion of patients that underwent diagnostic evaluations without an abnormal finding (false positives). The latter is multiplied by the decision threshold, which represents the estimated harms of the diagnostic intervention, such as patients' burden and use of available resources, against the harms of an outcome event, i.e. missing a urinary tract tumor.

This will be performed according to the Dutch guideline by administering validated questionnaires.

Patient-reported outcome measurements (PROMs) are assessed for patients undergoing cystoscopy and urine collection.

Erasmus Medical Center

Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers	NCT04260802	Cancer Neoplasms Metastatic Canc... Triple Negative... Gastric Cancer Cervical Cancer Ovarian Cancer Hepatocellular ... Squamous Cell C... Urothelial Carc... Urothelial Neop... Non Small Cell ... Renal Cell Carc... Locally Advance... Locally Advance... Squamous Cell C... Sarcoma Merkel Cell Car... Bladder Cancer	OC-001 OC-001 in Combi...	18 Years -	Ocellaris Pharma, Inc.
Safely Reduce Cystoscopic Evaluations for Hematuria Patients	NCT06026189	Hematuria Urothelial Neop... Urothelial Carc... Bladder Cancer	urine-first str...	-	Erasmus Medical Center
Safely Reduce Cystoscopic Evaluations for Hematuria Patients	NCT06026189	Hematuria Urothelial Neop... Urothelial Carc... Bladder Cancer	urine-first str...	-	Erasmus Medical Center

Spots Global Cancer Trial Database for urothelial neoplasm