Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2020-09-18
2030-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Nonagen Bioscience Corporation
INDUSTRY
University of California, San Francisco
OTHER
Kyoto University
OTHER
University of California, Los Angeles
OTHER
Cedars-Sinai Medical Center
OTHER
Responsible Party
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Charles Rosser
Professor
Principal Investigators
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Charles Rosser, MD
Role: STUDY_DIRECTOR
Nonagen Bioscience Corporation
Hideki Furuya, PhD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
UCSF
San Francisco, California, United States
University of Texas Southwestern
Dallas, Texas, United States
Kyoto University
Kyoto, Kyoto, Japan
Countries
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Central Contacts
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Facility Contacts
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Arnold Chin, MD
Role: primary
Sima Porten, MD
Role: primary
Yuki Kita, MD
Role: primary
References
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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.
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.
Other Identifiers
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CR2020-1113-0
Identifier Type: -
Identifier Source: org_study_id
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