Status:
COMPLETED
Addressing Colorectal Cancer in South Florida Firefighters
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Florida
Conditions:
Colorectal Cancer
CRC
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
The standard way of screening for colorectal cancer is to have a series of fecal blood tests, where a sample is taken from a participant's stool, or an endoscopic procedure performed by a doctor, wher...
Eligibility Criteria
Inclusion
- For this study, participation is open to active and retired firefighters:
- ≥ 40 and ≤ 65 years of age,
- who work or worked in Florida Fire and Rescue departments and
- report never having fecal occult blood test (FOBT) or sigmoidoscopy/colonoscopy in their life or only one FOBT in the past year, a sigmoidoscopy in the last 5 years or a colonoscopy in the last 10 years. The research assistant will assess eligibility using a brief screener that will be completed online via RedCAP.
- For years 2 and 3 of the study, the investigators will enroll previously eligible participants who did not complete colorectal cancer (CRC) screening during year 1. The investigators will also enroll participants who completed fecal immunochemical test (FIT) with our study during year 1 and 2. They will be contacted via RedCAP and a follow up phone call at the 1 year mark of their previous screening. Based on national guidelines, FIT screening is suggested on a yearly basis. The eligibility criteria will be the same and participants will sign a revised informed consent form, stating that they understand that they are being re-consented for the same study.
- Participants, ages 50-65 years old, meeting the above criteria who declined the offered standard-of-care FIT will then be offered the blood-based septin9 test 90 days from the initial offering. FDA guidelines require the participant to be at least 50 years old to participate in the septin9 blood collection. The blood based test will be collected by a nurse or certified phlebotomist in the community setting.
Exclusion
- Individuals, who have a personal history of CRC, inflammatory bowel disease (ie, Crohn disease involving the colon or ulcerative colitis) will be excluded from participation as these conditions increase the likelihood of positive test results not associated with the onset or recurrence of CRC disease. Additionally, individuals will be excluded if they are not physically capable of performing the FIT themselves.
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Key Trial Info
Start Date :
March 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2019
Estimated Enrollment :
646 Patients enrolled
Trial Details
Trial ID
NCT05976282
Start Date
March 15 2016
End Date
November 19 2019
Last Update
August 4 2023
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136