Clinical trial NCT05551052: CRC Detection Reliable Assessment With Blood
Official title: Prospective, Multi-center Observational Study for the Clinical Validation of the Next Generation Test for Blood-based Screening of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: 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
Lead sponsor: New Day Diagnostics
Sponsor class: NETWORK
First posted: 2022-09-22
Enrollment: 196
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy

Brief 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.

Eligibility 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

Primary outcomes:
measure: Sensitivity for CRC of the Next-Gen CRC Screening Test
timeFrame: blood collection up to 90 days from colonoscopy
measure: Specificity for CRC of the Next-Gen CRC Screening Test
timeFrame: blood collection up to 90 days from colonoscopy
Secondary outcomes:
measure: Sensitivity for advanced precancerous lesions of the Next-Gen CRC Screening Test
timeFrame: blood collection up to 90 days from colonoscopy
measure: Specificity for no colorectal neoplastic findings of the Next-Gen CRC Screening Test
timeFrame: blood collection up to 90 days from colonoscopy
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Gastro SB
state: California
city: San Diego
country: United States
facility: SDG Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
Study officials:
References: