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An observational study to evaluate RAS gene status in blood in advanced colorectal cancer patients with RAS Mutation

An observational study to evaluate RAS mutation in circulating-tumor DNA after chemotherapies in metastatic colorectal cancer patients with tumors harboring RAS mutation - JACCRO CC-17

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000043442
Enrollment
300
Registered
2021-02-26
Start date
2021-04-01
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

colorectal cancer

Interventions

None listed

Sponsors

Japan Clinical Cancer Research Organization (JACCRO)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (2) unresectable or metastatic colorectal cancer (3) histopathologically confirmed adenocarcinoma with RAS wild-type (4) 20 years and more at informed consent (5) refractory disease or unable to tolerate after gained the response of fluoropyrimidine containing regimen (6) schedule the testing of OncoBEAMTM RAS CRC kit (7) An estimated life expectancy of at least 90 days after enrollment (8) Ability to understand and the willingness to sign a written informed consent document

Exclusion criteria

Exclusion criteria: (1) Another malignancy with less than 5 disease-free years (2) Patients whose participation in the trial was judged to be inappropriate by the attending doctor

Design outcomes

Primary

MeasureTime frame
the frequency of RAS wild in ctDNA

Secondary

MeasureTime frame
(1) mutation allele frequency of RAS mutation in ctDNA (2) regarding all chemotherapies in enrolled patients overall response rate:ORR disease control rate:DCR overall survival:OS progression-free survival:PFS (3) regarding anti-EGFR antibody containing regimen in enrolled patients treatment cycle safety

Countries

Japan

Contacts

Public ContactNaoki IZAWA

St. Marianna University School of Medicine Department of Clinical Oncology

n2izawa@marianna-u.ac.jp044-977-8111

Outcome results

None listed

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