RECRUITING

Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)

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Conditions

Non-muscle-invasive Bladder CancerNMIBCBladder cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multi-center study and the aim is to develop and validate an Artificial Intelligence (AI) -based histologic analysis tool to predict responsiveness to intravesical Bacillus Calmette-Guérin (BCG) and intravesical chemotherapy in intermediate and high-risk non-muscle invasive bladder cancer patients.

Official Title

Predicting Outcomes in Intermediate and High-risk Non-muscle Invasive Bladder Cancer Using Automated Analysis of Digital Pathology Data

Quick Facts

Study Start:2024-01-25
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05825950

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of intermediate or high-risk non-muscle invasive bladder cancer as defined by AUA/SUO criteria (Intermediate-risk: recurrence within 1 year low grade Ta, solitary low grade Ta \>3 cm, multifocal low grade Ta, high grade Ta ≤3 cm, low grade T1; High risk: high grade T1, recurrent high grade Ta, high grade Ta \>3 cm, multifocal high grade Ta, any CIS, any BCG failure in high grade disease, any variant histology, any lymphovascular invasion) following pathologic evaluation of tissue specimens from TURBT.
  2. * Intravesical therapy within 6 months from enrollment including patients treated with BCG, mitomycin C, or Gemcitabine/Docetaxel.
  3. * English or Spanish speakers
  4. * ≥ 18 years of age
  5. * Ability to understand and the willingness to provide an informed consent
  1. * Inadequate tissue from TURBT
  2. * \> T2 bladder cancer
  3. * Systemic therapy
  4. * Inability to read or write English or Spanish
  5. * Unwilling to sign written informed consent

Contacts and Locations

Study Contact

Jacob Taylor, MD
CONTACT
214-645-8791
Jacob.Taylor@UTSouthwestern.edu

Principal Investigator

Yair Lotan, MD
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9164
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Yair Lotan, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-25
Study Completion Date2025-06

Study Record Updates

Study Start Date2024-01-25
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • NMIBC
  • Bladder cancer

Additional Relevant MeSH Terms

  • Non-muscle-invasive Bladder Cancer