Non-invasive Identification of Colorectal Cancer and Adenomas in Early Stages
NICE
1 other identifier
observational
3,002
1 country
12
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2022
CompletedStudy Start
First participant enrolled
May 13, 2022
CompletedFirst Posted
Study publicly available on registry
July 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2024
CompletedApril 23, 2024
August 1, 2023
1.9 years
April 21, 2022
April 22, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
Interventions
This is an observational, non interventional study
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Any active malignancy
- Any other illness that in the opinion of the investigator, makes the subject not a good candidate for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
East View Medical Research, LLD
Mobile, Alabama, 36606, United States
Paragon Rx Clinical
Garden Grove, California, 92840, United States
Paragon Rx Clinical
Santa Ana, California, 92703, United States
Encore - Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003, United States
Encore - Nature Coast Clinical Research
Inverness, Florida, 34452, United States
Encore - Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Encore Borland Groover
Jacksonville, Florida, 32256, United States
Encore - St. Johns Center for Clinical Research
Saint Augustine, Florida, 32086, United States
Combined Gastro Research, LLC
Lafayette, Louisiana, 70503, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105, United States
Allied Health Clinical Research Organization
Freehold, New Jersey, 07728, United States
Blue Ridge Medical Research
Lynchburg, Virginia, 24502, United States
Related Links
Biospecimen
blood sample will be collected at baseline for all subjects. blood sample will be collected at follow-up for a subgroup of subjects.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Daniel Hommes, MD
InterVenn Biosciences
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2022
First Posted
July 6, 2022
Study Start
May 13, 2022
Primary Completion
March 19, 2024
Study Completion
March 19, 2024
Last Updated
April 23, 2024
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share
No individual participant data will be shared.