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

Colorectal Cancer Clinical Trial

— NICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05445570
• Other study ID #: NICE-001
• Status: Completed
• Start date: May 13, 2022
• Est. completion date: March 19, 2024

Study information

• Verified date: August 2023
• Source: Venn Biosciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3002
• Est. completion date: March 19, 2024
• Est. primary completion date: March 19, 2024
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Diagnostic Test:
• Non-Interventional
This is an observational, non interventional study

Locations

Country	Name	City	State
United States	Encore - Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	Allied Health Clinical Research Organization	Freehold	New Jersey
United States	Paragon Rx Clinical	Garden Grove	California
United States	Encore - Nature Coast Clinical Research	Inverness	Florida
United States	Encore - Westside Center for Clinical Research	Jacksonville	Florida
United States	Encore Borland Groover	Jacksonville	Florida
United States	Combined Gastro Research, LLC	Lafayette	Louisiana
United States	Blue Ridge Medical Research	Lynchburg	Virginia
United States	East View Medical Research, LLD	Mobile	Alabama
United States	Encore - St. Johns Center for Clinical Research	Saint Augustine	Florida
United States	Paragon Rx Clinical	Santa Ana	California
United States	Louisiana Research Center, LLC	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Venn Biosciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the InterVenn test	To determine the sensitivity of the InterVenn test	up to 90 days from baseline
Primary	Specificity of the InterVenn test	To determine the specificity of the InterVenn test	up to 90 days from baseline

External Links

•   Sponsor Website