Uptake to Colorectal Cancer Screening in Familial-risk Population

Not Applicable

Completed

• Conditions: Colorectal Cancer; Screening Uptake of Colonoscopy and FIT
• Interventions: Procedure: annual FIT and colonoscopy in case of a positive test; Procedure: colonoscopy with sedation

• Registration Number: NCT02567045
• Lead Sponsor: Hospital Universitario de Canarias

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.

Study Timeline

• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-02
• Study Start: 2016-02-25
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-24
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fecal occult blood testing	annual FIT and colonoscopy in case of a positive test	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.
one-time Colonoscopy	colonoscopy with sedation	One-time Colonoscopy with sedation
Fecal occult blood testing	colonoscopy with sedation	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients who participate in each screening arm	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Federico Sopeña Biarge; 🇪🇸 Zaragoza, Aragón, Spain

Cristina Alvarez Urturi, MD; 🇪🇸 Barcelona, Cataluña, Spain

Maria Teresa Ocaña Bombardo; 🇪🇸 Barcelona, Cataluña, Spain

Patricia Muñoz Garrrido; 🇪🇸 San Sebastián, País Vasco, Gipuzcoa, Spain

Inés Castro Novo; 🇪🇸 Ourense, Galicia, Spain

Digestive Service, Huc; 🇪🇸 La Laguna, S/C DE Tenerife, Spain

María Rodriguez Soler; 🇪🇸 Alicante, Spain