Colorectal Cancer
Conditions
Brief summary
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
Detailed description
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.
Interventions
DIAGNOSTIC_TESTNon-Interventional
This is an observational, non interventional study
Sponsors
Venn Biosciences Corporation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Inclusion criteria
1. Male or female subjects between the ages of 45-85. 2. Able to provide an informed consent and who understand and agree to all study procedures required 3. Subject is scheduled or will soon be scheduled to receive a colonoscopy as ordered by their doctor.
Exclusion criteria
1. Any active malignancy 2. Any other illness that in the opinion of the investigator, makes the subject not a good candidate for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of the InterVenn test | up to 90 days from baseline | To determine the sensitivity of the InterVenn test |
| Specificity of the InterVenn test | up to 90 days from baseline | To determine the specificity of the InterVenn test |
Countries
United States
Outcome results
None listed