CRC Detection Reliable Assessment With Blood

Trial Title: CRC Detection Reliable Assessment With Blood

NCT ID: NCT05551052

Condition: Colorectal Cancer
Adenomas Colon
Colon Cancer
Rectal Cancer
Colon Neoplasm
Colon Lesion
Colon Disease
Colon Polyp
Polyps
Adenoma
Rectal Diseases
Rectal Polyp
Gastrointestinal Neoplasms
Intestinal Neoplasms
Colonic Diseases, Functional
Intestinal Disease

Conditions: Official terms:
Neoplasms
Colorectal Neoplasms
Colonic Neoplasms
Adenoma
Gastrointestinal Neoplasms
Digestive System Neoplasms
Intestinal Neoplasms
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases, Functional
Polyps

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Next-Gen CRC Screening Test
Description: The Next-Gen CRC Screening Test is a blood-based screening test for detection of CRC.
Arm group label: Next-Gen CRC Screening Test

Summary: The CRC DRAW study will assess the sensitivity and specificity of the blood-based, Next-Gen CRC Screening Test for the detection of CRC.

Detailed description: The CRC DRAW study is a prospective, multi-center, observational study to validate the Next-Gen CRC Screening test for the detection of CRC. The study will collect blood samples from average-risk participants scheduled for screening colonoscopies.

Criteria for eligibility:

Study pop:
Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: 1. Participant is 45 years of age or older at time of enrollment. 2. Participant is at average risk for development of colorectal cancer (as defined by inclusion and exclusion criteria) 3. Participant is able and willing to undergo a screening colonoscopy 4. Participant is able and willing to sign informed consent and adhere to study requirements 5. Participant is able to provide blood sample prior to colonoscopy (within 90 days of scheduled colonoscopy). Exclusion Criteria: 1. Previous personal history of CRC or precancerous lesions 2. Positive result from non-invasive screening test within the associated recommended intervals: 2.1 Fecal occult blood test or fecal immunochemical test within the previous 12 months 2.2 Epi proColon test within the previous 12 months 2.3 FIT-DNA (Cologuard) test within the previous 36 months 3. Diagnosed with condition associated with higher risk for colorectal cancer, such as: 3.1 Inflammatory bowel disease (IBD) 3.2 Chronic ulcerative colitis (CUC) 3.3 Crohn's disease 3.4 Familial adenomatous polyposis (FAP) 3.5 Familial history for colorectal cancer 3.5.1 One or more first-degree relatives diagnosed with CRC or adenomatous polyps before 60 years of age 3.5.2 Two or more first degree relatives diagnosed at any age with CRC 4. Individuals with relevant familial (hereditary) cancer syndrome, such as: 4.1 Hereditary non-polyposis colorectal cancer syndrome (HNPCC or Lynch Syndrome) 4.2 Peutz-Jeghers Syndrome 4.3 MYH-Associated Polyposis (MAP) 4.4 Gardner's syndrome 4.5Turcot's (or Crail's) syndrome 4.6 Cowden's syndrome, 4.7Juvenile Polyposis 4.8 Cronkhite-Canada syndrome 4.9 Neurofibromatosis 4.10 Familial Hyperplastic Polyposis 5. Diagnosed with chronic gastritis or cirrhosis 6. Current diagnosis of any cancer, except non-melanoma skin cancer 7. Overt rectal bleeding or bleeding hemorrhoids within previous 30 days 8. A colonoscopy within the previous 9 years, with the exception of a failed colonoscopy due to poor bowel preparation 9. Pregnancy

Gender: All

Minimum age: 45 Years

Maximum age: N/A

Locations:

Facility:
Name: Gastro SB

Address:
City: Chula Vista
Zip: 91910
Country: United States

Facility:
Name: SDG Clinical Research

Address:
City: San Diego
Zip: 92103
Country: United States

Facility:
Name: Medical Associates Research Group

Address:
City: San Diego
Zip: 92123
Country: United States

Start date: September 8, 2022

Completion date: July 2024

Lead sponsor:
Agency: Epigenomics, Inc
Agency class: Industry

Source: Epigenomics, Inc

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05551052