Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
196 participants
OBSERVATIONAL
2022-09-08
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Next-Gen CRC Screening Test
Adults 45 years of age and older who are at average risk of developing colorectal cancer and eligible for a screening colonoscopy
Next-Gen CRC Screening Test
The Next-Gen CRC Screening Test is a blood-based screening test for detection of CRC.
Interventions
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Next-Gen CRC Screening Test
The Next-Gen CRC Screening Test is a blood-based screening test for detection of CRC.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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).
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
45 Years
ALL
No
Sponsors
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New Day Diagnostics
NETWORK
Responsible Party
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Locations
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Gastro SB
Chula Vista, California, United States
SDG Clinical Research
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
Countries
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Other Identifiers
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SPR0033P
Identifier Type: -
Identifier Source: org_study_id
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