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This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pr e- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.
The Sponsor has identified cfDNA (circulating free-DNA) alterations (including methylation, fragmentation, and copy-number variance) that allow specific detection of colorectal cancer (CRC) advanced precancerous lesions (APL) and is in the process of developing a bloodbased test for early detection of colorectal cancer. The Sponsor is performing the current study to evaluate and optimize the performance of a preliminary panel of markers to finalize the assay for the use for US population. This study is designed to prospectively collect blood samples and clinical data from patients that have been newly diagnosed with colorectal cancer and scheduled for resection surgery but are pre cancer treatment, subjects who are NOT scheduled for surgery but have histological confirmation of CRC from the diagnostic colonoscopy and clinical staging (cTMN) is available and are pre- treatment, and patients who are at average risk of colorectal cancer and who are scheduled for routine colonoscopy examinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Patients newly diagnosed with CRC who have not yet had treatment or surgery. | ||
| Arm B | People at average risk of CRC undergoing screening for colorectal cancer with colonoscopy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Development of assay | The primary objective of this study is to optimize and evaluate the performance, including sensitivity and specificity, of the preliminary cfDNA marker panel to detect CRC and APL. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| ML Training | A portion of the samples will be used to train the ML algorithms and for assay development activities. Another purpose of the study is to collect samples to be used in Analytical Validation (Assay Verification) and system validation. | Through study completion to extend up to 24 months post LPI |
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Inclusion Criteria:
Exclusion Criteria:
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Prevalent colorectal cancer and people undergoing screening for colorectal cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Jesus Merino Calvo | Contact | 674945571 | antonio.merino@universaldx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology and Internal Medicine Specialists | Recruiting | Lake Barrington | Illinois | 60010 | United States |
Company IP.
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Whole blood.
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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