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

NCT ID: NCT05445570

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3002 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-13

Study Completion Date

2024-03-19

Brief Summary

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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

Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Non-Interventional

This is an observational, non interventional study

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Venn Biosciences Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Hommes, MD

Role: STUDY_DIRECTOR

InterVenn Biosciences

Locations

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East View Medical Research, LLD

Mobile, Alabama, United States

Site Status

Paragon Rx Clinical

Garden Grove, California, United States

Site Status

Paragon Rx Clinical

Santa Ana, California, United States

Site Status

Encore - Fleming Island Center for Clinical Research

Fleming Island, Florida, United States

Site Status

Encore - Nature Coast Clinical Research

Inverness, Florida, United States

Site Status

Encore - Westside Center for Clinical Research

Jacksonville, Florida, United States

Site Status

Encore Borland Groover

Jacksonville, Florida, United States

Site Status

Encore - St. Johns Center for Clinical Research

Saint Augustine, Florida, United States

Site Status

Combined Gastro Research, LLC

Lafayette, Louisiana, United States

Site Status

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Site Status

Allied Health Clinical Research Organization

Freehold, New Jersey, United States

Site Status

Blue Ridge Medical Research

Lynchburg, Virginia, United States

Site Status

Countries

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United States

Related Links

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https://intervenn.com/

Sponsor Website

Other Identifiers

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NICE-001

Identifier Type: -

Identifier Source: org_study_id

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