Uptake to Colorectal Cancer Screening in Familial-risk Population

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.

Sex

All

Minimum age

18 Years

Maximum age

40 Years

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.

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• RESULTPappadopulos 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. PMID 19307987
• RESULTDove-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. PMID 16243849
• DERIVEDGonzalez-Lopez N, Quintero E, Gimeno-Garcia AZ, Bujanda L, Banales J, Cubiella J, Salve-Bouzo M, Herrero-Rivas JM, Cid-Delgado E, Alvarez-Sanchez V, Ledo-Rodriguez A, de-Castro-Parga ML, Fernandez-Poceiro R, Sanroman-Alvarez L, Santiago-Garcia J, Herreros-de-Tejada A, Ocana-Bombardo T, Balaguer F, Rodriguez-Soler M, Jover R, Ponce M, Alvarez-Urturi C, Bessa X, Roncales MP, Sopena F, Lanas A, Nicolas-Perez D, Adrian-de-Ganzo Z, Carrillo-Palau M, Gonzalez-Davila E; Oncology Group of Asociacion Espanola de Gastroenterologia. Screening uptake of colonoscopy versus fecal immunochemical testing in first-degree relatives of patients with non-syndromic colorectal cancer: A multicenter, open-label, parallel-group, randomized trial (ParCoFit study). PLoS Med. 2023 Oct 24;20(10):e1004298. doi: 10.1371/journal.pmed.1004298. eCollection 2023 Oct.