Non-invasive Identification of Colorectal Cancer and Adenomas in Early Stages
- Conditions
- Colorectal Cancer
- Registration Number
- NCT05445570
- Lead Sponsor
- Venn Biosciences Corporation
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3002
- 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.
- Any active malignancy
- Any other illness that in the opinion of the investigator, makes the subject not a good candidate for the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Specificity of the InterVenn test up to 90 days from baseline To determine the specificity of the InterVenn test
Sensitivity of the InterVenn test up to 90 days from baseline To determine the sensitivity of the InterVenn test
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
East View Medical Research, LLD
🇺🇸Mobile, Alabama, United States
Combined Gastro Research, LLC
🇺🇸Lafayette, Louisiana, United States
Paragon Rx Clinical
🇺🇸Santa Ana, California, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Encore - Fleming Island Center for Clinical Research
🇺🇸Fleming Island, Florida, 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
Encore - St. Johns Center for Clinical Research
🇺🇸Saint Augustine, Florida, United States
Allied Health Clinical Research Organization
🇺🇸Freehold, New Jersey, United States
Blue Ridge Medical Research
🇺🇸Lynchburg, Virginia, United States