Non-invasive Identification of Colorectal Cancer and Adenomas in Early Stages

Venn Biosciences Corporation3,002 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,002

Conditions

Colorectal Cancer

Interventions

Non-InterventionalDIAGNOSTIC_TEST

This is an observational, non interventional study

Eligibility

Sex: ALLMin age: 45 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (12)

East View Medical Research, LLD

Mobile, Alabama, United States

Paragon Rx Clinical

Garden Grove, California, United States

Paragon Rx Clinical

Santa Ana, California, United States

Outcomes

Primary Outcomes

Sensitivity of the InterVenn test

To determine the sensitivity of the InterVenn test

Time frame: up to 90 days from baseline

Specificity of the InterVenn test

To determine the specificity of the InterVenn test

Time frame: up to 90 days from baseline

Data from ClinicalTrials.gov

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