Recruiting NCT04564781
Predicting BCG Response
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bladder Cancer. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Novel Multiplex Immunoassay for Predicting Intravesical BCG Response in Patients With Intermediate or High-risk Non-muscle Invasive Bladder Cancer
Overview
To date, there are no diagnostics capable of predicting treatment response to intravesical BCG. Because of this severe limitation, nearly 50% of patients treated with BCG fail therapy and will a) require additional intravesical therapy or b) require cystectomy. A urine-based diagnostic that possesses the potential to accurately identify patients who will respond favorably to intravesical BCG is desperately needed.
Primary outcome measures
- Sensitivity and specificity of multiplex immunoassay will be confirmed by surveillance cystoscopy. [Time frame: present through 04/30/2027]
Secondary outcome measures (1)
- Sensitivity and specificity of multiplex immunoassay will be compared to panel of urinary cytokines. [Time frame: present through 04/30/2027]
Eligibility criteria
Inclusion criteria
- Age 18 years or older
- Patients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder diagnosed within 90 days prior to scheduled BCG
- Patients must have had all grossly visible papillary tumors removed within 30 days prior to scheduled BCG or cystoscopy confirming no grossly visible papillary tumors within 30 days prior to scheduled BCG
- Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of nodal involvement or metastatic disease (CT scan or MRI scan) within 90 days prior to scheduled BCG
- Patients must have intermediate or high-grade bladder cancer as defined by 2004 WHO/ISUP classification
- Patients must not have pure squamous cell carcinoma or adenocarcinoma.
- Patients' disease must not have micropapillary components.
- Patients must have no evidence of upper tract (renal pelvis or ureters) cancer confirmed by one of the following tests performed within 90 days prior to BCG: CT urogram, intravenous pyelogram, MR urogram, or retrograde pyelograms.
- No other prior non-bladder malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible.
- Participants may be treated with immediate post-operative intravesical instillation of a chemotherapeutic agent
- Scheduled to undergo intravesical BCG therapy within 4 weeks of signing consent.
- Willing and able to give written informed consent (see Appendix 1)
- Willing to provide voided urine sample
Exclusion criteria
- Previous intravesical BCG therapy
- Patients must not be taking oral glucocorticoids at the time of registration.
- Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study.
- Patients must not have known history of tuberculosis.
- Have incomplete TUR, i.e., visible residual disease
- Have had radical cystectomy
- Have a known active urinary tract infection or urinary retention
- Have active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0 mg/dL) - Serum creatinine value can be up to 2 years before consent, otherwise repeat.
- Have ureteral stents, nephrostomy tubes or bowel interposition
- Have recent genitourinary instrumentation (within 7 days prior to signing consent)
- Be unable or unwilling to complete BCG induction and maintenance regimen
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 4 centers
- Cedars-Sinai Medical Center — Los Angeles
- UCLA — Los Angeles
- UCSF — San Francisco
- University of Texas Southwestern — Dallas
Australia · 1 center
- University of Queensland — Brisbane
Japan · 1 center
- Kyoto University — Kyoto
Publications
- Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. J Transl Med. 2024 Jan 2;22(1):8. doi: 10.1186/s12967-023-04811-2. PMID 38167321
- Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. Res Sq [Preprint]. 2023 Nov 25:rs.3.rs-3635581. doi: 10.21203/rs.3.rs-3635581/v1. PMID 38045238
Identifiers
NCT: NCT04564781 · CR2020-1113-0 · R01CA198887