Predictors of Residual Tumor at Second Transurethral Resection for pT1 Non-muscle Invasive Bladder Cancer

NCT06205277 | Completed

• 1 other identifier: 113/21
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

The START study is a multicentre retrospective project. The aim is to identify clinico-pathological predictors of residual tumor at time of second transurethral resection of bladder tumor (re-TURBt) and to identify well-selected candidates for a risk-adapted strategy in which this procedure could be safely spared.

Conditions

Bladder Cancer; Non Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Patients with histologically confirmed evidence of residual tumor at second TURBt

  Patients with histologically confirmed evidence of residual tumor at second TURBt defined as any pT BCa

  6 to 8 weeks

Study Arms (1)

Patients with pT1 NMIBC who underwent second TURBt

Patients with pT1 NMIBC who underwent second TURBt after a macroscopically completede first TURBt within 6-8 weeks

Procedure: Second TURBt

Interventions

Second TURBt PROCEDURE

Second TURBt for pT1 NMIBC as per current EAU Guidelines.

Patients with pT1 NMIBC who underwent second TURBt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All pT1 NMIBC patients after a macroscopically completed first TURBt who underwent second TURBt within 6-8 weeks as per current EAU Guidelines.

You may qualify if:

• patients undergoing second TURBt (re-TURBt) for pT1LG/HG NMIBC after a macroscopically completed first TURBt (in patients with multiple lesions only the index lesion pT1 conditioning the indication of re-TURBt will be considered). Therefore, presence of residual tumor or not at time of re-TURBt will be assessed at site of previous pT1.
• patients able to provide written informed consent;
• clinical-localized non-metastatic disease (cN0, cM0).

You may not qualify if:

• patients with clinical non-localized BCa (cN+, cM+);
• patients with incomplete resection at time of first TURBt according to surgeon: macroscopic evidence of residual tumor, too long resection requiring a second-look will be excluded from the current study;
• patients with incomplete clinical or demographic or pathological data;
• patients who were unable to provide written informed consent;
• patients who underwent urgency or emergency procedures in life-threating scenario

Sponsors & Collaborators

• University of Trieste: lead

Study Sites (1)

University of Trieste - Azienda Ospedaliera Universitaria Giuliano Isontina

Trieste, Friuli Venezia Giulia, 34149, Italy

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)