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Investigational Research of Biomarkers for Anti-EGFR Monoclonal Antibodies by Next Generation Sequencing

Investigational Research of Biomarkers for Anti-EGFR Monoclonal Antibodies by Next Generation Sequencing - Investigational Research of Biomarkers for Anti-EGFR Monoclonal Antibodies by Next Generation Sequencing

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000013720
Enrollment
40
Registered
2014-04-15
Start date
2014-04-16
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

St. Marianna University School of Medicine
Lead Sponsor
Kinki University School of Medicine, Department of Genome Biology
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patient with histologically confirmed primary adenocarcinoma. 2)Patient with advanced or recurrent colorectal carcinoma. 3)Patient with KRAS exon2 codon12/13 wild colorectal cancer. 4)Patient with lesion confirmed by imaging tests before chemotherapy. 5)Patient with metastatic colorectal cancer with measurable lesion according to RECIST ver.1.1 6)Patients who plan to receive chemotherapy including anti-EGFR antibody. 7)Patients who plan to receive imaging tests within 3 months after commencement of chemotherapy. 8)Age over 20. 9)Patient with metastatic colorectal cancer whose paraffin-embedded samples were obtained enough at St Marianna University School of Medicine Hospital . 10) Patient with written informed consent. 11) Patient who can provide bloody specimens before chemotherapy.

Exclusion criteria

Exclusion criteria: 1) Patient with simultaneous or metachronous double cancers except carcinoma in situ or intramucosal tumor. 2) Patient with active bacterial or fungous infection. 3) Patient with uncontrollable pleural effusion or ascites. 4) Patient with history of interstitial neumonitis to pulmonary fibrosis. 5) Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial.

Design outcomes

Primary

MeasureTime frame
Incidence and location of gene mutation corresponding to response to anti-EGFR antibody

Countries

Japan

Contacts

Public ContactTakuro Mizukami

St. Marianna University School of Medicine Department of clinical oncology

t3mizukami@marianna-u.ac.jp0449778111

Outcome results

None listed

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