ctDNA-based monitoring in muscle-invasive bladder cancer

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

This observational study collects blood, tissue, and urine samples to measure tumor-derived DNA using whole genome sequencing in patients with newly diagnosed, muscle-invasive urothelial carcinoma. Researchers will compare ctDNA positivity with clinical outcomes to see if it aligns with treatment response or recurrence. The study does not involve therapeutic intervention beyond standard care and uses a non-interventional design. It aims to improve understanding of ctDNA as a biomarker for residual disease and recurrence after curative-intent therapy. Participants include adults planned for surgery or radiation-based therapy with curative intent at a single center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ability to understand and willingness to provide written informed consent
* Age ≥ 18 yr at the time of consent. Eligibility is limited to adults since MIBC is not prevalent in persons under the age of 18 yr. Persons of all genders, gender identities, races, and ethnicity will be included
* New diagnosis of histologically confirmed muscle-invasive UC (TNM classification (UICC/AJCC 8th edition) of cT2-4aN0-2M0 at pathological examination and approved for either (1) systemic NAT followed by RC or (2) CRT

  * Plan for treatment of MIBC with curative intent with one of the three SOC treatments as listed above

    * Surgical resection, if planned, must include removal of the bladder and bilateral pelvic lymph node dissection if not already included
    * Radiation therapy, if planned, must include transurethral resection of bladder tumor, followed by image guided radiotherapy plus sensitizing chemotherapy
* Representative FFPE tumor specimens from biopsy at diagnosis (including TURBT) in paraffin blocks (blocks preferred) or at least 10 unstained and 1 H\&E slides. Biopsied tumor specimen quality must have been verified by local pathology review. Fine-needle aspiration, brushing, cell pellet from pleural effusion, and lavage samples are not acceptable. For core-needle biopsy specimens, at least three cores should be submitted for evaluation
* For participants who have partners of childbearing potential: Partner and/or participant must not be planning to conceive and must follow guidelines and recommendations per the SOC for their various therapeutic interventions

Exclusion Criteria:

* Ongoing treatment with an approved or investigational anti-cancer therapy for a cancer that is distinct from UC. Hormone-replacement therapy or oral contraceptives are allowed. Ongoing systemic therapy for bladder cancer will not be exclusionary, but enrollment of this population will be limited
* Previous or concurrent cancer that is distinct from the cancer under investigation in primary site or histology, except treated cutaneous basal cell carcinoma or squamous cell carcinoma, low or intermediate risk prostate cancer under active surveillance, myeloproliferative disorders or indolent hematologic malignancies that do not require active systemic therapy, and small renal masses under active surveillance. Any cancer curatively treated \>two years prior to the first treatment for bladder cancer is permitted

Where it's running

• OHSU Knight Cancer Institute
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Jen-Jane Liu — OHSU Knight Cancer Institute

Similar studies

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

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• Immunotherapy plus radiation to avoid bladder removal after chemo for muscle-invasive bladder cancer

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• Combining enfortumab vedotin and pembrolizumab with radiation for muscle invasive bladder cancer

  This study is testing a new combination of a drug and radiation therapy to see if it helps people with muscle invasive bladder cancer who want to avoid surgery.

  Recruiting Phase 1/2 University of California, San Francisco · San Francisco, California · NCT06470282

• Combining futibatinib and durvalumab before bladder cancer surgery for patients who can't use cisplatin

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• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

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• Combination treatment for muscle-invasive bladder cancer

  This study is testing a new combination of two medications to see if they can help people with muscle-invasive bladder cancer avoid surgery and improve their treatment outcomes.

  Recruiting at 5 sites Phase 2 Hoosier Cancer Research Network · Duarte, California and 4 other locations · NCT06809140

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.