Colorectal Cancer, Screening Uptake of Colonoscopy and FIT
Conditions
Keywords
Immunochemical fecal occult blood test, Colonoscopy, Screening uptake, Screening participation, Familiar risk, Colorectal Cancer
Brief summary
This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of fecal occult blood test (FIT) versus one-time screening colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC). The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.
Detailed description
This is a multicenter, controlled, randomized phase III study to compare participation rate with two screening rounds of FIT versus one-time screening colonoscopy in FDR of patients diagnosed of CRC. The recruitment process will be programmed through the index case, that will be interviewed to obtain their CRC family history. FDR will be contacted in order to make an appointment in the High-risk CRC Clinic of the participant centers. Randomization will be performed before signing the informed consent to avoid selection bias. A researcher will be responsible to provide detailed information about the study and getting the informed consent. In case of willingness to participate in the study, the FDR will be randomized to one of the following arms: A) One-time colonoscopy; B) annual FIT for two screening rounds and a colonoscopy in case of a positive FIT (cut-off = 10 μg Hemoglobin/g feces). Screening uptake will be defined as the percentage of FDR who participate at least in one of the two FIT screening round in the FIT group or who undergo colonoscopy in the other group. Screening uptake will be calculated under the assumption of intention to screen analysis. The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary to include in each group.
Interventions
PROCEDUREannual FIT and colonoscopy in case of a positive test
FIT and colonoscopy in case of a positive test. Annual interval (2 rounds), without diet restriction, 1 stool sample. Positive cut-off 10 mcg Hemoglobin/g feces.
PROCEDUREcolonoscopy with sedation
One-time Colonoscopy with sedation.
Sponsors
Hospital Universitario de Canarias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Masking description
Participants were randomized to either colonoscopy or faecal occult blood test
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. FDR with a case index meeting the following conditions: at least one case index \< 60 years at diagnosis of the CCR; 2. having ≥ 2 FDRs with CRC regardless the age of the case index at diagnosis; 3. having a sibling with CRC; 4. age \<75 years.
Exclusion criteria
1. past CRC screening; 2. inflammatory bowel disease or past history of colorectal neoplasia; 3. Family history of hereditary CRC; 4. Abdominal symptoms; 5. Colectomy; 6. Severe comorbidity leading to a poor prognosis (life expectancy \< 5 years); 7. Refusal to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who participate in each screening arm | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy measure: QALYs (Quality adjusted life years). | 2 years |
| Costs measure: cost (euros) of the procedures associated with each screening strategy and treatment of advanced neoplastic lesions | 2 years |
Countries
Spain
Outcome results
None listed