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The purpose of this study is to collect clinical specimens from subjects with a diagnosis of colorectal cancer/advanced adenoma or undergoing a screening colonoscopy and meeting study eligibility criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Cohort A will include subjects with a recent diagnosis of colorectal cancer and/or advanced adenoma requiring additional endoscopic or surgical resection (surgery). |
| |
| Cohort B | Cohort B will include subjects undergoing routine screening colonoscopies will be enrolled in the screening cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FirstSight blood test | Diagnostic Test | FirstSight blood test for colorectal cancer screening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity for CRC of the FirstSight test | 30 days | |
| Specificity of the FirstSight test | 30 days |
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Inclusion Criteria:
To enroll in Cohort A, a subject must:
To enroll in Cohort B, a subject must:
Exclusion Criteria:
To enroll in Cohort A, a subject must NOT have:
To enroll in Cohort B, a subject must NOT have:
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Cohort A: This cohort will include subjects with a recent diagnosis of colorectal cancer or advanced adenoma requiring surgical resection.
Cohort B: This cohort will include subjects undergoing routine screening colonoscopies for colorectal cancer as part of their regular medical assessment regimen.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ben Hsieh, PhD | Contact | 650-814-8088 | ben@cellmaxlife.com | |
| Stephen Su, PhD | Contact | 408-887-7640 | stephensu@cellmaxlife.com |
| Name | Affiliation | Role |
|---|---|---|
| Rui Mei, PhD | CellMax Life | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CellMax Site A | Active, not recruiting | Huntsville | Alabama | 35801 | United States | |
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| CellMax Site O |
| Recruiting |
| Chula Vista |
| California |
| 91910 |
| United States |
| CellMax Site L | Recruiting | Lancaster | California | 93534 | United States |
| CellMax Site J | Recruiting | Tustin | California | 92780 | United States |
| CellMax Site P | Recruiting | Coral Gables | Florida | 33134 | United States |
| CellMax Site D | Recruiting | Coral Springs | Florida | 33067 | United States |
| CellMax Site G | Recruiting | Coral Springs | Florida | 33067 | United States |
| CellMax Site C | Recruiting | Miami | Florida | 33125 | United States |
| CellMax Site B | Recruiting | Metairie | Louisiana | 70006 | United States |
| CellMax Site N | Recruiting | Mentor | Ohio | 44060 | United States |
| CellMax Site M | Recruiting | Camp Hill | Pennsylvania | 17011 | United States |
| CellMax Site K | Recruiting | Houston | Texas | 77084 | United States |
| CellMax Site E | Recruiting | McAllen | Texas | 78539 | United States |
| CellMax Site F | Recruiting | Pasadena | Texas | 77504 | United States |
| CellMax Site H | Recruiting | San Antonio | Texas | 78212 | United States |