Biomarker Analysis in Metastatic Colorectal Cancer Treated With Cetuximab
NCT ID: NCT02029326
Last Updated: 2017-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2010-02-01
2015-08-26
Brief Summary
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We planned this study to explore biomarkers predictive of clinical response to cetuximab-based treatment in metastatic colorectal cancer using the Prometheus Platform. We will also elucidate signal transduction pathway attributable to cetuximab resistance, monitor changes in the RTK activation status during cetuximab treatment using circulating tumor cells and analyze correlation between the quantity of circulating tumor cells and treatment response to cetuximab.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Cetuximab-based chemotherapy (monotherapy, combination therapy with cytotoxic chemotherapy such as FOLFOX, XELOX, irinotecan, FOLFIRI, XELIRI, first-line, second-line or third-line are all eligible)
* Age \> 18 years.
* ECOG Performance Status of 0-2
* Adequate bone marrow, liver and renal function
* Signed and dated informed consent before the start of specific protocol procedures.
* FNA will be performed in patients with feasible biopsy site; ascites or pleural fluid will be collected in metastatic CRC patients with ascites or pleural effusion
Exclusion Criteria
* Patients with evidence or history of bleeding diathesis
* Radiotherapy during study or within 4 weeks of start of study drug.
* Prior exposure to the study drug.
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Joon Oh Park
MD, PhD
Locations
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Samsung Medical Center
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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2009-09-074
Identifier Type: -
Identifier Source: org_study_id
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