Taking people in United StatesNo phase

Urine Test to Predict Response to BCG Bladder Cancer Treatment

Studies a urine test that may predict which bladder cancer patients respond to BCG therapy.

Key facts

Who runs it: Cedars-Sinai Medical Center
Where: Dallas, Los Angeles, and San Francisco, United StatesSee the 4 sitesAlso in 2 other countries, 2 sites
Trial code: NCT04564781
Registry title: Predicting BCG Response
Status: Recruiting
People taking part: 400 people, planned
Started: 18 Sept 2020
Expected to end: Feb 2030
Type of study: Observational
Record updated: 6 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with newly diagnosed intermediate or high-risk non-muscle invasive bladder cancer who are about to start BCG treatment in the bladder. A urine sample is collected to see who responds to BCG.

Age: 18 to 90 years
Sex: All sexes can join.
Disease stage: Urothelial bladder cancer of stage Ta, carcinoma in situ (CIS) or T1, diagnosed within 90 days before BCG, with intermediate or high-grade disease. No visible tumors left. No spread to lymph nodes or elsewhere in T1 disease. No cancer in the upper urinary tract.
Earlier treatment: Scheduled to start BCG in the bladder within 4 weeks of signing consent. No earlier BCG in the bladder. Visible tumors removed within 30 days before BCG. One dose of chemotherapy into the bladder right after surgery is allowed.

Main reasons for not taking part

Earlier BCG treatment in the bladder
Pure squamous cell cancer, adenocarcinoma or micropapillary parts in the tumor
Known tuberculosis or taking oral glucocorticoids
Active urinary infection, urinary retention or kidney or bladder stones
Radical cystectomy, ureteral stents or nephrostomy tubes

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

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

Who cannot take part

Previous intravesical BCG therapy
Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study
Have recent genitourinary instrumentation (within 7 days prior to signing consent)
Patients must not have known history of tuberculosis
Have incomplete TUR, i.e., visible residual disease
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
Patients must not be taking oral glucocorticoids at the time of registration
Have had radical cystectomy
Have ureteral stents, nephrostomy tubes or bowel interposition
Be unable or unwilling to complete BCG induction and maintenance regimen

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 90 years old?

Where in United States

Also in 2 other countries, 2 sites

University of Texas, SouthwesternDallas, United StatesContact: Perla LopezTaking people
Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Amy OppenheimTaking people
UCLALos Angeles, United StatesContact: Arnold Chin, MDTaking people
UCSFSan Francisco, United StatesContact: Sima Porten, MDTaking people

About the trial

What the trial wants to find out

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.