RECRUITING

Predicting BCG Response

Talk to us

Conditions

Bladder Cancer

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Novel Multiplex Immunoassay for Predicting Intravesical BCG Response in Patients With Intermediate or High-risk Non-muscle Invasive Bladder Cancer

Quick Facts

Study Start:2020-09-18
Study Completion:2026-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04564781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * 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
  3. * 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
  4. * 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
  5. * Patients must have intermediate or high-grade bladder cancer as defined by 2004 WHO/ISUP classification
  6. * Patients must not have pure squamous cell carcinoma or adenocarcinoma.
  7. * Patients' disease must not have micropapillary components.
  8. * 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.
  9. * 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.
  10. * Participants may be treated with immediate post-operative intravesical instillation of a chemotherapeutic agent
  11. * Scheduled to undergo intravesical BCG therapy within 4 weeks of signing consent.
  12. * Willing and able to give written informed consent (see Appendix 1)
  13. * Willing to provide voided urine sample
  1. * Previous intravesical BCG therapy
  2. * Patients must not be taking oral glucocorticoids at the time of registration.
  3. * Patients must not be planning to receive concomitant biologic therapy, hormonal therapy, chemotherapy, surgery, or other cancer therapy while on study.
  4. * Patients must not have known history of tuberculosis.
  5. * Have incomplete TUR, i.e., visible residual disease
  6. * Have had radical cystectomy
  7. * Have a known active urinary tract infection or urinary retention
  8. * 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.
  9. * Have ureteral stents, nephrostomy tubes or bowel interposition
  10. * Have recent genitourinary instrumentation (within 7 days prior to signing consent)
  11. * Be unable or unwilling to complete BCG induction and maintenance regimen

Contacts and Locations

Study Contact

Charles Rosser, MD
CONTACT
3104233713
Charles.rosser@cshs.org
Amy Oppenheimer
CONTACT
3104233713
Amy.Oppenheim@cshs.org

Principal Investigator

Charles Rosser, MD
STUDY_DIRECTOR
Nonagen Bioscience Corporation
Hideki Furuya, PhD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
UCLA
Los Angeles, California, 90095
United States
UCSF
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Charles Rosser, MD, STUDY_DIRECTOR, Nonagen Bioscience Corporation
  • Hideki Furuya, PhD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-18
Study Completion Date2026-12-30

Study Record Updates

Study Start Date2020-09-18
Study Completion Date2026-12-30

Terms related to this study

Additional Relevant MeSH Terms

  • Bladder Cancer