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Prospective observational study to evaluate clinical utility of FoundationObe CDx

Prospective observational study to evaluate clinical utility of FoundationObe CDx - Prospective observational study to evaluate clinical utility of FoundationObe CDx

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000034830
Enrollment
200
Registered
2018-11-10
Start date
2018-11-12
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

gastrointestinal cancer, rare cancer and cancer of unknown primary

Interventions

None listed

Sponsors

Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with histologically diagnosed stage III/IV(UICC-TNM 8th)gastrointestinal cancer, rare cancer and cancer of unknown primary 2. Written informed consent 3. Formalin Fixed Paraffin Embedded(FFPE)cancer tissue is available for pathological diagnosis, and remaining cancer tissue is enough for genomic sequencing test as well. 4. Age >= 16 years 5. Previously untreated cancer patients. The following patients will be allowed: patients treated with oral anticancer drugs as adjuvant therapy and patients with sufficient FFPE tissue obtained before the start of anticancer drugs. 6. Patients with recurrent disease inside irradiation field will be excluded. (If tissue is available from a recurrent tumor outside the irradiation field, the patient can be included.) 7. For a recurrence case, it has to be less than 3 years after surgery.

Exclusion criteria

Exclusion criteria: 1. Patients without available tumor tissue 2. Patients judged to be inappropriate for the study by investigators

Design outcomes

Primary

MeasureTime frame
Detection rate of actionable/druggable cancer genomic alterations using FoundationOne CDx

Countries

Japan

Contacts

Public ContactTomohiro Kondo

Kyoto University Hospital Clinical Oncology

fmi_kuhp@kuhp.kyoto-u.ac.jp075-751-3518

Outcome results

None listed

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