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Clinical validity of mutated DNA monitoring in plasma and urinary pellet in recurrent diagnosis of bladder cancer

Clinical validity of mutated DNA monitoring in plasma and urinary pellet in recurrent diagnosis of bladder cancer - Mutated DNA monitoring in plasma and urinary pellet in recurrent diagnosis of bladder cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000045792
Enrollment
40
Registered
2021-11-01
Start date
2019-11-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer

Interventions

None listed

Sponsors

Iwate Medical University Institute for Biomedical Sciences Division of Biomedical Research and Development
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Those who have agreed to participate in the research 2) Cases in which TUR-Bt is performed for high-risk bladder cancer (multiple, recurrence, T1 or higher, high grade, including CIS, etc.), or within 2 years after the operation 3) Histological diagnosis of urothelial cancer 4) Expected life expectancy is 6 months or more 5) With or without additional postoperative therapy (2nd TUR-Bt, BCG therapy, chemotherapy, total cystectomy) 6) Regardless of recurrence / regrowth and treatment status at the start of blood collection 7) Regardless of age, gender, performance states, etc.

Exclusion criteria

Exclusion criteria: 1) Patients who have difficulty in outpatient visits 2) Patients with psychiatric symptoms who have difficulty participating in the study 3) Patients with serious complications 4) Patients judged by the principal investigator to be inappropriate for registration 5) Cases in which pathological diagnosis and sequence analysis cannot be compatible due to the small amount of tumor sample

Design outcomes

Primary

MeasureTime frame
Diagnostic lead time(day precedes relapse diagnosis by imaging modalities)

Secondary

MeasureTime frame
Decrease of plasma and urinary pellet VAF or disappearance of mutant alleles in recurrence-free cases

Countries

Japan

Contacts

Public ContactMasakazu Abe

Iwate Medical University Institute for Biomedical Sciences Division of Biomedical Research and Development

amasa@iwate-med.ac.jp019-651-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026