Bladder Cancer Trial, Recruiting NCT04564781 Sponsor: Cedars-Sinai Medical Center Condition: Bladder Cancer
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Bladder Cancer Trial, Recruiting

NCT04564781
Recruiting Not Applicable 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older
  • You have been diagnosed with a specific type of bladder cancer (urothelial cell carcinoma) at an early stage (called Ta, CIS, or T1), confirmed by a tissue sample taken within the last 90 days
  • Any visible tumors in your bladder have been removed, or a scope test has confirmed no visible tumors, within the last 30 days
  • If you have T1 stage cancer, a recent CT or MRI scan of your abdomen and pelvis (within 90 days) has shown no sign the cancer has spread to lymph nodes or other areas
  • Your bladder cancer has been classified as intermediate or high grade according to standard medical guidelines
  • Any previous cancer you may have had was either a minor skin cancer, early-stage cervical cancer, an early-stage cancer now in full remission, or any cancer you have been free of for at least five years
  • If you have prostate cancer, it must be low-risk and being managed through an active monitoring programme rather than active treatment
  • You are scheduled to begin BCG bladder treatment within 4 weeks of signing the consent form
  • You are willing and able to sign a consent form
  • You are willing to provide a urine sample
  • You may have received a one-time chemotherapy wash inside the bladder immediately after your tumour removal surgery

Who may not be able to join:

  • You have previously received BCG bladder treatment
  • You are currently taking steroid tablets (oral glucocorticoids) at the time of enrolment
  • You are planning to receive any other cancer treatments — such as biological therapy, hormone therapy, chemotherapy, or surgery — at the same time as this study
  • You have a known history of tuberculosis
  • You still have visible tumour remaining after your bladder surgery
  • You have already had your bladder surgically removed
  • You currently have an active urinary tract infection or difficulty passing urine (urinary retention)
  • You have active kidney or bladder stones, or your kidneys are not working well enough (confirm with trial site for specific test values)
  • You have a ureteral stent, a nephrostomy tube, or bowel used to reconstruct part of your urinary system (confirm with trial site)
  • You have had any procedure involving your urinary or genital tract within the last 7 days before signing consent
  • You are unable or unwilling to complete the full course of BCG treatment, including both the initial and maintenance phases
  • Your bladder cancer is a pure squamous cell carcinoma or adenocarcinoma type
  • Your bladder cancer has a feature called micropapillary components
  • You have signs of cancer in your upper urinary tract (kidneys or ureters), based on a scan or imaging test done within the last 90 days

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Charles Rosser, MD, Nonagen Bioscience Corporation

Phone: 3104233713

Australian sites

University of Queensland, Brisbane,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Cedars-Sinai Medical Center
Registry
ClinicalTrials.gov
Start date
18 September 2020
Est. completion
1 February 2030

Where this trial is recruiting

🇦🇺 Australia 🇯🇵 Japan 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Sensitivity and specificity of multiplex immunoassay will be confirmed by surveillance cystoscopy.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov