Uptake to Colorectal Cancer Screening in Familial-risk Population

Study Overview
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Brief Summary
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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
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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.

Official Title
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Uptake to Colorectal Cancer Screening in Familiar-risk Population: A Randomized Controlled Trial Comparing Immunochemical Fecal Occult Blood Test With Colonoscopy

Conditions
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Colorectal Cancer, Screening Uptake of Colonoscopy and FIT

Intervention / Treatment
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* Procedure: annual FIT and colonoscopy in case of a positive test
* Procedure: colonoscopy with sedation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FDR with a case index meeting the following conditions: at least one case index < 60 years at diagnosis of the CCR; having ≥ 2 FDRs with CRC regardless the age of the case index at diagnosis; having a sibling with CRC; age <75 years. Exclusion Criteria: past CRC screening; inflammatory bowel disease or past history of colorectal neoplasia; Family history of hereditary CRC; Abdominal symptoms; Colectomy; Severe comorbidity leading to a poor prognosis (life expectancy < 5 years); Refusal to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecal occult blood testing<br>Annual FIT and colonoscopy in case of a positive test. Fecal occult blood testing: annual FIT (two rounds) without diet restriction, one stool sample. Positive cut-off = 10 μg Hemoglobin/g feces. Colonoscopy will be performed in case of a positive FIT. | Procedure: annual FIT and colonoscopy in case of a positive test<br>* 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.<br>Procedure: colonoscopy with sedation<br>* One-time Colonoscopy with sedation.<br>|
| Active Comparator: one-time Colonoscopy<br>One-time Colonoscopy with sedation | Procedure: colonoscopy with sedation<br>* One-time Colonoscopy with sedation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who participate in each screening arm |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunochemical fecal occult blood test, Colonoscopy, Screening uptake, Screening participation, Familiar risk, Colorectal Cancer