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Prometheus's Onco dX assay platform provides technological breakthrough for immunoassay by obtaining a level of sensitivity down to single tumor cells without compromising specificity. This allows assessment of multiple TKI treatment targets, their activation status, as well as down stream signaling proteins using very tiny amount of tissue that can be obtained by FNA or CTCs.
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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| Measure | Description | Time Frame |
|---|---|---|
| To explore biomarkers predictive of clinical response to cetuximab-based treatment in metastatic colorectal cancer using the Prometheus Platform | A. To analyze expression and activation status of receptor tyrosine kinases in signal transduction pathways in FNA samples and circulating tumor cells B. To identify negative predictive markers to cetuximab | at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months(end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 1. RTK activation status during cetuximab treatment using circulating tumor cells | at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months(end of treatment) | |
| 2. signal transduction pathway attributable to cetuximab resistance | at Screening (Day - 21 ~ 0 ), at 4 weeks and EOT (end of treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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colorectal cancer patients who are treated with cetuximab
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| 3. To analyze correlation between the quantity of circulating tumor cells and treatment response to cetuximab | at Screening (Day - 21 ~ 0 ), at 4 weeks and average 6months (end of treatment) |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |