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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05445570
Recruitment Status : Active, not recruiting
First Posted : July 6, 2022
Last Update Posted : November 10, 2022
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Colorectal Cancer Diagnostic Test: Non-Interventional

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.

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Study Type : Observational
Actual Enrollment : 3002 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Non-invasive Identification of Colorectal Cancer and Adenomas in Early Stages
Actual Study Start Date : May 13, 2022
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : June 30, 2023

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


Primary Outcome Measures :
  1. Sensitivity of the InterVenn test [ Time Frame: up to 90 days from baseline ]
    To determine the sensitivity of the InterVenn test

  2. Specificity of the InterVenn test [ Time Frame: up to 90 days from baseline ]
    To determine the specificity of the InterVenn test


Biospecimen Retention:   Samples With DNA
blood sample will be collected at baseline for all subjects. blood sample will be collected at follow-up for a subgroup of subjects.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05445570


Locations
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United States, Alabama
East View Medical Research, LLD
Mobile, Alabama, United States, 36606
United States, California
Paragon Rx Clinical
Garden Grove, California, United States, 92840
Paragon Rx Clinical
Santa Ana, California, United States, 92703
United States, Florida
Encore - Fleming Island Center for Clinical Research
Fleming Island, Florida, United States, 32003
Encore - Nature Coast Clinical Research
Inverness, Florida, United States, 34452
Encore - Westside Center for Clinical Research
Jacksonville, Florida, United States, 32205
Encore Borland Groover
Jacksonville, Florida, United States, 32256
Encore - St. Johns Center for Clinical Research
Saint Augustine, Florida, United States, 32086
United States, Louisiana
Combined Gastro Research, LLC
Lafayette, Louisiana, United States, 70503
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71105
United States, New Jersey
Allied Health Clinical Research Organization
Freehold, New Jersey, United States, 07728
United States, Virginia
Blue Ridge Medical Research
Lynchburg, Virginia, United States, 24502
Sponsors and Collaborators
Venn Biosciences Corporation
Investigators
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Study Director: Daniel Hommes, MD InterVenn Biosciences
Additional Information:
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Responsible Party: Venn Biosciences Corporation
ClinicalTrials.gov Identifier: NCT05445570    
Other Study ID Numbers: NICE-001
First Posted: July 6, 2022    Key Record Dates
Last Update Posted: November 10, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type