Non-muscle-invasive Bladder Cancer
Conditions
Keywords
NMIBC, Bladder cancer
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.
Detailed description
Analysis will be performed on the most recent Transurethral resection of bladder tumor (TURBT) histologic specimen obtained prior to BCG induction and on histologic specimens at time of recurrence after BCG induction. This stratification is of potential utility to clinicians for patient counseling purposes, for the identification of patients likely to benefit from induction or re-induction with BCG, and for consideration of alternative treatment strategies including clinical trials, chemotherapy, or cystectomy. Additionally, there is currently no reliable tool for identifying which NMIBC patients are most likely to benefit from adjuvant BCG versus intravesical chemotherapy. This is of current relevance in the management of Intermediate-risk (IR) NMIBC since both BCG and chemotherapy are first-line treatment options and will likely become of increasing relevance in High-risk (HR) NMIBC as efficacious first-line alternatives to intravesical BCG are introduced into clinical practice. In the proposed prospective study, the study team also aims to develop and then validate an AI-based histologic analysis tool for clinicians that is intended to predict recurrence following intravesical chemotherapy in IR and HR NMIBC patients.
Interventions
None listed
Sponsors
University of Texas Southwestern Medical Center
Valar Labs
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence free survival (RFS) at 12 months after TURBT in patients with HR NMIBC | 12 months | Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of first procedure confirming histopathological recurrence, disease progression or death as a first event from any cause during surveillance cystoscopy at 12 months. |
| Recurrence free survival (RFS) at 3 months after TURBT in participants with HR NMIBC | 3 months | Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of first procedure confirming histopathological recurrence, disease progression or death as a first event from any cause during surveillance cystoscopy at 3 months. |
| Recurrence free survival (RFS) at 24 months after TURBT in patients with HR NMIBC | 24 months | Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of first procedure confirming histopathological recurrence, disease progression or death as a first event from any cause during surveillance cystoscopy at 24 months. |
| Recurrence free survival (RFS) at 6 months after TURBT in patients with HR NMIBC | 6 months | Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of first procedure confirming histopathological recurrence, disease progression or death as a first event from any cause during surveillance cystoscopy at 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence free survival (RFS) at 24 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC | 24 months | Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of negative surveillance cystoscopy after TURBT confirming histopathological recurrence, disease progression or death as a first event from any cause at 24 months. |
| Progression-free survival (PFS) at 12 months following the first negative surveillance cystoscopy after TURBT in patients with HR or IR NMIBC | 12 months | Progression-Free Survival is measured as the time from the patient registration to the date of first negative surveillance cystoscopy after TURBT in patients with HR or IR NMIBC or death from any cause in the absence of progression, whichever occurs first. An increase in tumor stage and/or the presence of muscle invasive disease diagnosed during surveillance cystoscopy will constitute disease progression. |
| Progression-free survival (PFS) at 24 months following the first negative surveillance cystoscopy after TURBT in patients with HR NMIBC or IR NMIBC | 24 months | Progression-Free Survival is measured as the time from the patient registration to the date of first negative surveillance cystoscopy after TURBT in patients with HR or IR NMIBC or death from any cause in the absence of progression, whichever occurs first. An increase in tumor stage and/or the presence of muscle invasive disease diagnosed during surveillance cystoscopy will constitute disease progression. |
| Recurrence free survival (RFS) at 3 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC | 3 months | Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of negative surveillance cystoscopy after TURBT confirming histopathological recurrence, disease progression or death as a first event from any cause at 3 months. |
| Recurrence free survival (RFS) at 6 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC | 6 months | Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of negative surveillance cystoscopy after TURBT confirming histopathological recurrence, disease progression or death as a first event from any cause at 6 months. |
| Recurrence free survival (RFS) at 12 months following the first negative surveillance cystoscopy after TURBT in patients with IR NMIBC | 12 months | Recurrence free survival (RFS) is measured as the time from start of clinical treatment / study enrollment to the date of negative surveillance cystoscopy after TURBT confirming histopathological recurrence, disease progression or death as a first event from any cause at 12 months. |
Countries
United States
Contacts
CONTACTJacob Taylor, MD
CONTACTSonobia Garrett
PRINCIPAL_INVESTIGATORYair Lotan, MD
University of Texas Southwestern Medical Center
Outcome results
None listed