400 Participants Needed

Predicting BCG Response

Recruiting at 3 trial locations
AO
CR
Overseen ByCharles Rosser, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cedars-Sinai Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

CR

Charles Rosser, MD

Principal Investigator

Nonagen Bioscience Corporation

HF

Hideki Furuya, PhD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravesical BCG treatment

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Intravesical BCG

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials
523
Recruited
165,000+

University of California, Los Angeles

Collaborator

Trials
1,594
Recruited
10,430,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Nonagen Bioscience Corporation

Industry Sponsor

Trials
5
Recruited
2,300+

University of California, San Francisco

Collaborator

Trials
2,636
Recruited
19,080,000+

University of Rochester

Collaborator

Trials
883
Recruited
555,000+

Kyoto University

Collaborator

Trials
38
Recruited
26,500+
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