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OpenTrials
Completed

NCT Number: NCT05445570

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

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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

East View Medical Research, LLD, Mobile, Alabama, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects between the ages of 45-85.
  • Able to provide an informed consent and who understand and agree to all study procedures required
  • Subject is scheduled or will soon be scheduled to receive a colonoscopy as ordered by their doctor.

Exclusion criteria

  • Any active malignancy
  • Any other illness that in the opinion of the investigator, makes the subject not a good candidate for the study.

Treatment and study plan

Non-Interventional

Diagnostic Test

This is an observational, non interventional study

Primary outcomes

  1. Sensitivity of the InterVenn test

    Time frame: up to 90 days from baseline

    To determine the sensitivity of the InterVenn test

  2. Specificity of the InterVenn test

    Time frame: up to 90 days from baseline

    To determine the specificity of the InterVenn test

Sponsors and collaborators

Lead sponsor

Venn Biosciences Corporation

Industry

Registry information

Acronym: NICE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 6, 2022
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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