Validation Study on Prediction of Response to BCG Instillation using SNP Kit Evaluation

Multicenter Prospective Observational Study on Prediction of Response to BCG Instillation using SNP Kit Evaluation in Patients with Highest-Risk Non-Muscle-Invasive Bladder Cancer - PRECISE-BCG Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1071250133

Enrollment

120

Registered

2026-02-24

Start date

2026-02-24

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

patients with highest-risk non-muscle-invasive bladder cancer (NMIBC) NMIBC, bladder cancer, non-muscle-invasive, highest-risk

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >=18 years at the time of signing the informed consent 2. Histologically confirmed high-grade T1 urothelial carcinoma within 84 days prior to enrollment that meets at least one of the following criteria for highest-risk non-muscle-invasive bladder cancer: - Concomitant CIS in the bladder or prostatic urethra - Multifocality, recurrence, or a maximum tumor diameter >=3 cm - Presence of variant histology or LVI 3. No evidence of muscle-invasive disease, regional lymph node metastasis (short-axis >=10 mm per RECIST version 1.1), or distant metastasis on imaging (chest CT and abdominal/pelvic CT or MRI) performed within 84 days prior to enrollment 4. Complete resection of all Ta/T1 lesions prior to enrollment 5. Planned to receive intravesical BCG therapy 6. Written informed consent obtained from the patient prior to participation in the study 7. ECOG PS of 0 or 1

Exclusion criteria

Exclusion criteria: 1. Presence of a mixed histological component of small cell carcinoma 2. History or concurrent diagnosis of renal pelvic/ureteral carcinoma or urethral carcinoma (excluding prostatic urethral carcinoma in men) 3. Prior intravesical BCG therapy (prior intravesical chemotherapy is permitted) 4. Previous exposure to investigational agents, systemic anticancer therapy, or radiotherapy for bladder cancer 5. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibody or agent specifically targeting T-cell co-stimulatory or checkpoint pathways 6. Any contraindication to intravesical BCG therapy 7. Presence of active other primary cancers 8. Inability to undergo intravesical therapy 9. Any condition for which the investigator judges participation in this study to be inappropriate

Design outcomes

Primary

Measure	Time frame
Event-Free Survival (EFS) by SNP	—

Secondary

Measure	Time frame
Progression-Free Survival (PFS) by SNP intravesical Recurrence-Free Survival (iRFS) by SNP Overall Survival (OS) by SNP	—

Contacts

Public ContactTakashi Matsumoto

Kyushu University Hospital

matsumoto.takashi.971@m.kyushu-u.ac.jp+81-92-642-5603

Outcome results