Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies

Study Overview
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Brief Summary
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The objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer. Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.

Detailed Description
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Patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be asked to submit a stool sample(s)(at least 7 days AFTER colonoscopy) and will have the option of submitting blood and tissue samples for future colo-rectal cancer-related test development.

Official Title
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Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies

Conditions
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Colorectal Neoplasms, Digestive System Diseases, Colonic Diseases, Colorectal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female, 40-90 years of age, inclusive. Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy and/or ≥1 cm colorectal polyp/adenoma/mass identified on a colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy. Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator. Exclusion Criteria: Subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer). Subject has a history of any inflammatory bowel disease. Subject has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Colorectal cancer patients<br>Subjects will be men and women, 40-90 years of age, inclusive, each with a colonoscopic biopsy-based diagnosis of colorectal cancer (CRC) and/or an intact pre-malignant colorectal lesion large enough to require surgical excision or complex colonoscopic polypectomy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms. | The diagnostic test under development is a multi-marker stool test for detecting CRC and pre-cancer in a general screening application. The primary objective of this study is to confirm the sensitivity of the optimal DNA marker panel. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect samples from patients diagnosed with colorectal cancers. | Residual samples from patients diagnosed with colorectal cancer will be archived for further research intended to help in the diagnosis of cancers. Specimens will be stored up to 10 years in the Sponsor's on-site bio-repository or similar commercial bio-repository contracted by the sponsor. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Colorectal Cancer, Neoplasm, Colorectal Neoplasm, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Rectal Diseases