Clinical trial NCT02567045: Uptake to Colorectal Cancer Screening in Familial-risk Population
Official title: Uptake to Colorectal Cancer Screening in Familiar-risk Population: A Randomized Controlled Trial Comparing Immunochemical Fecal Occult Blood Test With Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Screening Uptake of Colonoscopy and FIT
Keywords: Immunochemical fecal occult blood test
Colonoscopy
Screening uptake
Screening participation
Familiar risk
Colorectal Cancer
Lead sponsor: Hospital Universitario de Canarias
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients who participate in each screening arm
timeFrame: 2 years
Secondary outcomes:
measure: Efficacy measure: QALYs (Quality adjusted life years).
timeFrame: 2 years
measure: Costs measure: cost (euros) of the procedures associated with each screening strategy and treatment of advanced neoplastic lesions
timeFrame: 2 years
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Federico Sopeña Biarge
state: Aragón
city: Barcelona
country: Spain
facility: Cristina Alvarez Urturi, MD
state: Cataluña
city: Barcelona
country: Spain
facility: Maria Teresa Ocaña Bombardo
state: Cataluña
city: Ourense
country: Spain
facility: Inés Castro Novo
state: Galicia
city: San Sebastián
country: Spain
facility: Patricia Muñoz Garrrido
state: País Vasco, Gipuzcoa
city: La Laguna
country: Spain
facility: Digestive Service, Huc
state: S/C DE Tenerife
city: Alicante
country: Spain
facility: María Rodriguez Soler
Study officials:
affiliation: Hospital Universitario de Canarias
name: Enrique Quintero, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Quintero E, Carrillo M, Gimeno-Garcia AZ, Hernandez-Guerra M, Nicolas-Perez D, Alonso-Abreu I, Diez-Fuentes ML, Abraira V. Equivalency of fecal immunochemical tests and colonoscopy in familial colorectal cancer screening. Gastroenterology. 2014 Nov;147(5):1021-30.e1; quiz e16-7. doi: 10.1053/j.gastro.2014.08.004. Epub 2014 Aug 13.
citation: Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas A, Andreu M, Carballo F, Morillas JD, Hernandez C, Jover R, Montalvo I, Arenas J, Laredo E, Hernandez V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andres M, Teruel G, Peris A, Roncales MP, Polo-Tomas M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Diaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, Gonzalez-Navarro A; COLONPREV Study Investigators. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366(8):697-706. doi: 10.1056/NEJMoa1108895.
citation: Pappadopulos E, Jensen PS, Chait AR, Arnold LE, Swanson JM, Greenhill LL, Hechtman L, Chuang S, Wells KC, Pelham W, Cooper T, Elliott G, Newcorn JH. Medication adherence in the MTA: saliva methylphenidate samples versus parent report and mediating effect of concomitant behavioral treatment. J Am Acad Child Adolesc Psychiatry. 2009 May;48(5):501-510. doi: 10.1097/CHI.0b013e31819c23ed.
citation: Dove-Edwin I, Sasieni P, Adams J, Thomas HJ. Prevention of colorectal cancer by colonoscopic surveillance in individuals with a family history of colorectal cancer: 16 year, prospective, follow-up study. BMJ. 2005 Nov 5;331(7524):1047. doi: 10.1136/bmj.38606.794560.EB. Epub 2005 Oct 21.