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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Diagnostic test: Non-Interventional

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.

• Study Type: Observational
• Enrollment (Actual): 3002

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36606
      • East View Medical Research, LLD
  • California
    • Garden Grove, California, United States, 92840
      • Paragon Rx Clinical
    • Santa Ana, California, United States, 92703
      • Paragon Rx Clinical
  • Florida
    • Fleming Island, Florida, United States, 32003
      • Encore - Fleming Island Center for Clinical Research
    • Inverness, Florida, United States, 34452
      • Encore - Nature Coast Clinical Research
    • Jacksonville, Florida, United States, 32205
      • ENCORE - Westside Center for Clinical Research
    • Jacksonville, Florida, United States, 32256
      • Encore Borland Groover
    • Saint Augustine, Florida, United States, 32086
      • ENCORE - St. Johns Center for Clinical Research
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • Combined Gastro Research, LLC
    • Shreveport, Louisiana, United States, 71105
      • Louisiana Research Center, LLC
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Allied Health Clinical Research Organization
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Blue Ridge Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Venn Biosciences Corporation
• Investigators: Study Director: Daniel Hommes, MD, InterVenn Biosciences

Publications and helpful links

Helpful Links

• Sponsor Website

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): March 19, 2024
• Study Completion (Actual): March 19, 2024

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: NICE-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No