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| ID | Type | Description | Link |
|---|---|---|---|
| CALGB-SWOG-150506-80405-BRAF | |||
| CDR0000688745 | Registry Identifier | NCI Physician Data Query |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Studying samples of tissue in the laboratory from patients who received cetuximab may help doctors understand and predict how well patients will respond to treatment.
PURPOSE: This research study is studying biomarkers in predicting response to cetuximab in patients with advanced colorectal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Previously collected formalin-fixed and paraffin-embedded baseline tumor samples are analyzed for BRAF V600E mutation. Mutation status is correlated with clinical response and outcome data from patients enrolled on CALGB-C80405.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Correlative (BRAF V600E mutation analysis) | Previously collected formalin-fixed and paraffin-embedded baseline tumor samples are analyzed for BRAF V600E mutation. Mutation status is correlated with clinical response and outcome data from patients enrolled on CALGB-C80405. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mutation analysis | Genetic |
| ||
| laboratory biomarker analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival as measured by RECIST | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Up to 36 months | |
| tumor response as measured by RECIST | Up to 36 months |
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DISEASE CHARACTERISTICS:
Participation in CALGB-C80405
Have KRAS WT or KRAS mut tumor
Randomized to treatment with either bevacizumab or cetuximab alone
Available specimens at the PCO for BRAF mutation detection
Patient consent for use of samples
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Patients previously enrolled on CALGB-C80405 who have KRAS WT or KRAS mut tumor and have been randomized to treatment with either bevacizumab or cetuximab alone in a primary care clinic setting.
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| Name | Affiliation | Role |
|---|---|---|
| Najjia N. Mahmoud, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Tissue
| Other |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |