Using urine tumor DNA to guide whether to have a second bladder tumor resection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with non‑muscle‑invasive urothelial bladder cancer who had an initial TURBT and meet criteria such as T1 stage, suspected incomplete resection, or absence of detrusor muscle will provide a 50 mL urine sample 2–6 weeks after the first surgery. The urine will be analyzed for tumor DNA (utDNA) and those results will be compared with findings from the planned second transurethral resection and pathological examination of tumor tissue. The trial will determine whether positive or negative utDNA reliably predicts residual tumor and therefore could inform the need for re‑TURBT. The protocol includes collection of tumor tissue and genetic testing and is conducted at multiple hospitals in China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Participants must meet all of the following criteria to be eligible for the study:

1. Male or female, aged 18 years or older.
2. Histologically confirmed non-muscle-invasive bladder tumor, with no evidence of muscle-invasive bladder cancer or metastatic disease.
3. Histologically confirmed urothelial carcinoma of the bladder or bladder tumor with urothelial carcinoma as the predominant component (\>50%).
4. At least one of the following conditions:

   1. Incomplete initial transurethral resection of bladder tumor (TURBT) or suspected incomplete resection.
   2. Absence of detrusor muscle in the initial TURBT pathological specimen (except for low-grade Ta stage tumors or carcinoma in situ \[CIS\]).
   3. T1 stage tumor.
5. Willingness to provide a 50 mL urine sample between 2-6 weeks after the initial TURBT and prior to re-TURBT.
6. Willingness to provide tumor tissue samples for pathological examination.
7. Willingness to undergo genetic testing required for the trial.

Exclusion Criteria:

1. Contraindications to transurethral resection of bladder tumor (TURBT).
2. Concurrent malignancy of the upper urinary tract (ureter or renal pelvis).

Where it's running

• Nanchang Second People's Hospital
  Nanchang, Anhui, China Recruiting
• Sun Yat-sen Memorial Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• Xingtai People's Hospital
  Xingtai, Hebei, China Recruiting
• The Second Affiliated Hospital of Kunming Medical University
  Kunming, Yunnan, China Recruiting
• Renji Hospital
  Shanghai, China Recruiting
• The Second Hospital of Tianjin Medical University
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Hailong Hu, MD
• Email: huhailong@tmu.edu.cn
• Phone: +8613662096232

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.