Predicting BCG Response

  • STATUS
    Recruiting
  • End date
    Dec 30, 2026
  • participants needed
    400
  • sponsor
    Cedars-Sinai Medical Center
Updated on 10 April 2022
carcinoma
carcinoma in situ
antineoplastic
cystoscopy
bladder tumor
intravesical bcg

Summary

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.

Details
Condition Bladder Cancer
Clinical Study IdentifierNCT04564781
SponsorCedars-Sinai Medical Center
Last Modified on10 April 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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