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The NICE study is a prospective, multi-site study to train and validate a blood-based, glycoproteomic test for the early detection of advanced adenoma and colorectal cancer by collecting blood samples and associated relevant clinical information from average-risk participants who undergo routine screening colonoscopy as well as participants undergoing colonoscopy for surveillance or diagnostic indications
InterVenn is using its glycoprotein profiling technology platform that couples high-resolution liquid chromatography (LC)-mass spectrometry (MS) with an artificial intelligence (AI), neural network (NN)-based high-throughput data processing software to identify patterns uniquely associated with colon adenoma and colon adenocarcinoma in order to detect (pre)cancerous events early. The purpose of this prospective multi-center observational study is to train and validate a blood-based, glycoproteomic test for the early detection of advanced adenoma and colorectal cancer by collecting blood samples and associated relevant clinical information from average-risk participants who undergo routine screening colonoscopy as well as participants undergoing colonoscopy for surveillance or diagnostic indications.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Diagnostic Test | This is an observational, non interventional study |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of the InterVenn test | To determine the sensitivity of the InterVenn test | up to 90 days from baseline |
| Specificity of the InterVenn test | To determine the specificity of the InterVenn test | up to 90 days from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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The study population comprises approximately 3000 subjects, male and female, between the ages of 45 and 85 who are scheduled for or will soon be scheduled for a screening, surveillance, or diagnostic colonoscopy.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Hommes, MD | InterVenn Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East View Medical Research, LLD | Mobile | Alabama | 36606 | United States | ||
| Paragon Rx Clinical |
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| Label | URL |
|---|---|
| Sponsor Website | View source |
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No individual participant data will be shared.
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blood sample will be collected at baseline for all subjects. blood sample will be collected at follow-up for a subgroup of subjects.
| Garden Grove |
| California |
| 92840 |
| United States |
| Paragon Rx Clinical | Santa Ana | California | 92703 | United States |
| Encore - Fleming Island Center for Clinical Research | Fleming Island | Florida | 32003 | United States |
| Encore - Nature Coast Clinical Research | Inverness | Florida | 34452 | United States |
| Encore - Westside Center for Clinical Research | Jacksonville | Florida | 32205 | United States |
| Encore Borland Groover | Jacksonville | Florida | 32256 | United States |
| Encore - St. Johns Center for Clinical Research | Saint Augustine | Florida | 32086 | United States |
| Combined Gastro Research, LLC | Lafayette | Louisiana | 70503 | United States |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | United States |
| Allied Health Clinical Research Organization | Freehold | New Jersey | 07728 | United States |
| Blue Ridge Medical Research | Lynchburg | Virginia | 24502 | United States |
| 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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