Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent TURBK.

NCT06167356 | Recruiting

• 1 other identifier: Prot. 2007-Vescica
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

A database has been created and will be used in which data will be collected in electronic format relating to adult patients who underwent one of the following endoscopic resection surgeries: TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES.

Conditions

Non Muscle Invasive Bladder Cancer; Non-Muscle Invasive Bladder Neoplasms; Non-Muscle Invasive Bladder Urothelial Carcinoma; Bladder Cancer; Bladder Disease; Bladder Neoplasm; Bladder Urothelial Carcinoma; Bladder Cancer Stage I, With Cancer in Situ; Bladder Cancer Recurrent; Bladder Urothelial Carcinoma in Situ; Bladder Urothelial Dysplasia

Keywords

Intravescical Therapies; Bladder Urothelial Carcinoma; Bladder Neoplasm; Bladder Disease; Bladder Cancer; Intravesical Instillations

Outcome Measures

Primary Outcomes (2)

• obtain health benefit for the patients themselves and for future patients suffering from bladder cancer

  All patients, before underwent endoscopic resection surgery, receive a diary in which we ask a detailed clinical history of the patient with their symptoms, diagnosis and previous urological e non urological treatments performed before the operation. A detailed intraoperative, postoperative and follow-up clinical history

  1 Annual follow-up from the date of surgery until the date in which patient decides to stop providing follow-up responses or until the date of death from any cause.

• improve the patient's scientific knowledge and develop new procedures for the diagnosis and treatment of the patient

  Through the collection of a detailed clinical history of the patient in which themselves report symptoms, diagnosis and previous urological and non-urological treatments and also through the medical record.

  1 Annual follow-up from the date of surgery untile the date in which patient decides to stop providing follow-up responses or until the date of death from any cause.

Study Arms (1)

Patients with non-muscle invasive bladder cancer

Patients with non-muscle invasive bladder cancer who underwent one of the following endoscopic resection surgeries : TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non muscle-invasive bladder cancer who underwent one of the following endoscopic resection surgeries : TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES

You may qualify if:

• years or older
• Patients with non-muscle invasive bladder cancer
• Indication to cancer removal through endoscopic resection surgery
• Ability to read and sign the informed consent

You may not qualify if:

• Age \<18 years
• Inability to read and sign the informed consent

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Urinary Bladder Neoplasms; Urinary Bladder Diseases

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Francesco Montorsi, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Montorsi, MD

CONTACT

+390226437286; montorsi.francesco@hsr.it

Giusy Burgio, MSc

CONTACT

+390226436764; burgio.giusy@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: December 12, 2023
• Study Start: November 27, 2013
• Primary Completion (Estimated): November 27, 2063
• Study Completion (Estimated): November 27, 2063
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)