NCT05825950 Artificial Intelligence Prediction Tool in Non-muscle Invasive Bladder Cancer (NMIBC)
| NCT ID | NCT05825950 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Non-muscle-invasive Bladder Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-01-25 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2024-01-25 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. * Intravesical therapy within 6 months from enrollment including patients treated with BCG, mitomycin C, or Gemcitabine/Docetaxel. * English or Spanish speakers * ≥ 18 years of age * Ability to understand and the willingness to provide an informed consent Exclusion Criteria: * Inadequate tissue from TURBT * ≥ T2 bladder cancer * Systemic therapy * Inability to read or write English or Spanish * Unwilling to sign written informed consent
Contact & Investigator
Yair Lotan, MD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT05825950 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Non-muscle-invasive Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05825950 currently recruiting?
Yes, NCT05825950 is actively recruiting participants. Contact the research team at Jacob.Taylor@UTSouthwestern.edu for enrollment information.
Where is the NCT05825950 trial being conducted?
This trial is being conducted at Dallas, United States, San Antonio, United States.
Who is sponsoring the NCT05825950 clinical trial?
NCT05825950 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Yair Lotan, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 600 participants.
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