Clinical trial NCT05445570: Non-invasive Identification of Colorectal Cancer and Adenomas in Early Stages
Official title: Non-invasive Identification of Colorectal Cancer and Adenomas in Early Stages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Venn Biosciences Corporation
Sponsor class: INDUSTRY
First posted: 2022-07-06
Enrollment: 3002
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of the InterVenn test
timeFrame: up to 90 days from baseline
measure: Specificity of the InterVenn test
timeFrame: up to 90 days from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: East View Medical Research, LLD
state: Alabama
city: Garden Grove
country: United States
facility: Paragon Rx Clinical
state: California
city: Santa Ana
country: United States
facility: Paragon Rx Clinical
state: California
city: Fleming Island
country: United States
facility: Encore - Fleming Island Center for Clinical Research
state: Florida
city: Inverness
country: United States
facility: Encore - Nature Coast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Encore - Westside Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Encore Borland Groover
state: Florida
city: Saint Augustine
country: United States
facility: Encore - St. Johns Center for Clinical Research
state: Florida
city: Lafayette
country: United States
facility: Combined Gastro Research, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Freehold
country: United States
facility: Allied Health Clinical Research Organization
state: New Jersey
city: Lynchburg
country: United States
facility: Blue Ridge Medical Research
state: Virginia
Study officials:
affiliation: InterVenn Biosciences
name: Daniel Hommes, MD
role: STUDY_DIRECTOR
References: