Uptake to Colorectal Cancer Screening in Familial-risk Population

NCT02567045 | Completed

• 1 other identifier: Colorectal cancer screening
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 7

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.

Conditions

Colorectal Cancer; Screening Uptake of Colonoscopy and FIT

Keywords

Immunochemical fecal occult blood test; Colonoscopy; Screening uptake; Screening participation; Familiar risk; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who participate in each screening arm

  2 years

Secondary Outcomes (2)

• 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

Study Arms (2)

Fecal occult blood testing

EXPERIMENTAL

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; Procedure: colonoscopy with sedation

one-time Colonoscopy

ACTIVE COMPARATOR

One-time Colonoscopy with sedation

Procedure: colonoscopy with sedation

Interventions

annual FIT and colonoscopy in case of a positive test PROCEDURE

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.

Fecal occult blood testing

colonoscopy with sedation PROCEDURE

One-time Colonoscopy with sedation.

Fecal occult blood testing; one-time Colonoscopy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead

Study Sites (7)

Federico Sopeña Biarge

Zaragoza, Aragon, 50009, Spain

Location

Cristina Alvarez Urturi, MD

Barcelona, Catalonia, 08003, Spain

Location

Maria Teresa Ocaña Bombardo

Barcelona, Catalonia, 08036, Spain

Location

Inés Castro Novo

Ourense, Galicia, 32005, Spain

Location

Patricia Muñoz Garrrido

San Sebastián, País Vasco, Gipuzcoa, 20080, Spain

Location

Digestive Service, Huc

San Cristóbal de La Laguna, S/C de Tenerife, 38320, Spain

Location

María Rodriguez Soler

Alicante, 03010, Spain

Location

Related Publications (5)

• 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.

  PMID: 25127679 RESULT

• 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.

  PMID: 22356323 RESULT

• 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.

  PMID: 19307987 RESULT

• 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.

  PMID: 16243849 RESULT

• Gonzalez-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.

  PMID: 37874831 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Enrique Quintero, MD, PhD

  Hospital Universitario de Canarias

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants were randomized to either colonoscopy or faecal occult blood test
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 2, 2015
• Study Start: February 25, 2016
• Primary Completion: December 31, 2019
• Study Completion: March 24, 2020
• Last Updated: August 10, 2020

Record last verified: 2020-08

Locations

ES (7)