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| Name | Class |
|---|---|
| Sequenom, Inc. | INDUSTRY |
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The study aims to provide a more complete characterization and understanding of the genetic causes of and tumor DNA detection potential in colorectal cancer. Ultimately findings of this study will be used to develop early detection tests for colorectal cancer that are minimally invasive (based on a blood test). It is hoped that reliable, minimally invasive, early detection methods will lead to improved screening rates, increased screening safety, longer colorectal cancer survival, and overall cost savings.
In order to assess the test's ability to detect tumor DNA, 25 participants with known colorectal cancer who will be undergoing surgical resection of the colon as part of their clinical care will be recruited. The investigators will collect blood from participants prior to surgery, tumor and normal tissue removed during surgery, a series of blood samples after surgery for up to one year and relevant medical records. DNA variants identified in blood will be compared against tissue samples. Serial samples will be analyzed to assess the variance in amount of circulating tumor DNA across time with standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | All subjects enrolled in the study will provide tumor and normal tissue and blood samples. |
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| Measure | Description | Time Frame |
|---|---|---|
| Determining sensitivity of assay in known cancer patients | The sensitivity (% positive out of all diseased patients) of circulating tumor DNA detection from the blood samples will be calculated against the gold standard of surgical pathology reports in this pilot group of patients with known colorectal cancer. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with colorectal cancer that will be receiving surgical removal of their cancer as part of their care.
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| Name | Affiliation | Role |
|---|---|---|
| Eric Topol, MD | Scripps Translational Science Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |