Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study

This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to d

Trial Details

NCT ID
NCT05987241
Phase
PHASE2 / PHASE3
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Non-Muscle-Invasive Bladder Cancer
Interventions
  • Biospecimen Collection
  • cfDNA or ctDNA Measurement
  • Computed Tomography
  • Cystoscopy
  • Magnetic Resonance Imaging
  • Nivolumab
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Tucson, Arizona, United States|32.22174,-110.92648

Key Eligibility Criteria

  • PRE-REGISTRATION (STEP 0): Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis
  • PRE-REGISTRATION (STEP 0): Variant histology, including neuroendocrine differentiation, sarcomatoid, micropapillary, glandular, trophoblastic, Mull…
  • PRE-REGISTRATION (STEP 0): Radical surgery (cystectomy with lymph node dissection or nephroureterectomy or ureterectomy) must be ≥ 3 weeks and ≤ 12…
  • PRE-REGISTRATION (STEP 0): Patients who have had a partial cystectomy as definitive therapy are not eligible

For full eligibility, visit ClinicalTrials.gov.

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