title: Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening.
abstract: OBJECTIVE
  Colonoscopy is the recommended screening procedure for first-degree relatives of patients with colorectal cancer (CRC), but few studies have compared its efficacy for CRC detection with that of other screening strategies. We conducted a controlled randomized trial to compare the efficacy of repeated fecal immunochemical tests (FITs) and colonoscopy in detecting advanced neoplasia (advanced adenoma or CRC) in family members of patients with CRC.
  
  
  METHODS
  In a prospective study, 1918 first-degree relatives of patients with CRC were randomly assigned (1:1 ratio) to receive a single colonoscopy examination or 3 FITs (1/year for 3 years; OC-Sensor; cutoff ≥10 μg hemoglobin/g feces, corresponding to 50 ng hemoglobin/mL buffer). The strategies were considered to be equivalent if the 95% confidence interval of the difference for the detection of advanced neoplasia was ±3%. Follow-up analyses were performed to identify false-negative FIT results and interval CRCs.
  
  
  RESULTS
  Of all eligible asymptomatic first-degree relatives, 782 were included in the colonoscopy group and 784 in the FIT group. In the intention-to-screen analysis, advanced neoplasia was detected in 33 (4.2%) and 44 (5.6%) first-degree relatives in the FIT and colonoscopy groups, respectively (odds ratio = 1.41; 95% confidence interval: 0.88-2.26; P = .14). In the per-protocol analysis, 28 first-degree relatives (3.9%) in the FIT group and 43 (5.8%) in the colonoscopy group had advanced neoplasia (odds ratio = 1.56; 95% confidence interval: 0.95-2.56; P = .08). FIT missed 16 of 41 advanced adenomas but no CRCs. The FIT strategy required endoscopic evaluation of 4-fold fewer individuals to detect 1 advanced neoplasia than the colonoscopy strategy.
  
  
  CONCLUSIONS
  Repeated FIT screening (1/year for 3 years) detected all CRCs and proved equivalent to colonoscopy in detecting advanced neoplasia in first-degree relatives of patients with CRC. This strategy should be considered for populations where compliance with FITs is higher than with colonoscopy. ClinicalTrials.gov number: NCT01075633 (COLONFAM Study).
authors.affiliation: Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain. Electronic address: equinter@gmail.com.
authors.forename: Enrique
authors.initials: E
authors.lastname: Quintero
authors.affiliation: Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Carrillo
authors.affiliation: Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain.
authors.forename: Antonio Z
authors.initials: AZ
authors.lastname: Gimeno-García
authors.affiliation: Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Hernández-Guerra
authors.affiliation: Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Nicolás-Pérez
authors.affiliation: Servicio de Gastroenterología, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) and Centro de Investigación Biomédica de Canarias (CIBICAN), Departamento de Medicina Interna, Universidad de La Laguna, La Laguna, Tenerife, Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Alonso-Abreu
authors.affiliation: Laboratorio Central, Hospital Universitario de Canarias, La Laguna, Tenerife, Spain.
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Díez-Fuentes
authors.affiliation: Unidad de Bioestadística Clínica, Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.
authors.forename: Víctor
authors.initials: V
authors.lastname: Abraira
mesh_terms: D000236:Adenoma / Q000737:chemistry / Q000175:diagnosis* / Q000235:genetics / Q000473:pathology; D000328:Adult; D014408:Biomarkers, Tumor / Q000032:analysis*; D003106:Colon / Q000473:pathology*; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000737:chemistry / Q000175:diagnosis* / Q000235:genetics / Q000473:pathology; D055088:Early Detection of Cancer / Q000379:methods*; D005188:False Negative Reactions; D005243:Feces / Q000737:chemistry*; D005260:Female; D020022:Genetic Predisposition to Disease; D006454:Hemoglobins / Q000032:analysis*; D040941:Heredity; D006801:Humans; D007120:Immunochemistry; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010349:Patient Compliance; D010375:Pedigree; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012307:Risk Factors; D013030:Spain; D013997:Time Factors
chemical_list: D014408:Biomarkers, Tumor; D006454:Hemoglobins
keywords: Colon Cancer; Colonoscopy Resources; Diagnostic Yield; Familial Colorectal Cancer