Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

Colorectal Cancer Clinical Trial

Official title:

Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906997
• Other study ID #: COLONPREV
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2024
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aims:

1. To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT) versus colonoscopy every 10 years for the reduction of colorectal cancer-related mortality at 10 years in average-risk population.

2. To determine the compliance and complications associated with both strategies.

Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias, Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia).

Study groups:

• Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive result.

• Group II: colonoscopy.

Sample-size calculation: 27,749 subjects in each study group (total: 55,498).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55498
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

Inclusion Criteria:

• Men and women aged 50-69 years

Exclusion Criteria:

• Personal history of colorectal cancer, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease

• Family history of colorectal polyposis, Lynch syndrome or familial colorectal cancer (2 or more first-degree relatives diagnosed with colorectal cancer or one first-degree relative diagnosed with colorectal cancer before the age of 60)

• Severe comorbidity

• Previous total colectomy

• Not signed informed consent to participate

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasm
• Colorectal Neoplasms

Intervention

Procedure:
• Immunochemical fecal occult blood test
Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.
• Colonoscopy
Every 10 years, with sedation.

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona
Spain	Hospital Clínico	Madrid
Spain	Hospital Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital Meixoeiro	Ourense
Spain	Hospital de Donosti	San Sebastián
Spain	Hospital Universitario de Canarias	Tenerife
Spain	Comunidad Valencia	Valencia
Spain	Hospital Clínico Lozano Blesa	Zaragoza

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Fundacion Cientifica de la Asociacion Española contra el Cancer, Gastrointestinal Oncology Group of the Spanish Gastroenterological Association, Grupo Cooperativo para el Cribado del Cancer Colorrectal en España., Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal cancer-related mortality		10 years
Secondary	Compliance rate		2 years
Secondary	Complication rate		10 years
Secondary	Colorectal cancer incidence		15 years
Secondary	Adherence rate		10 years
Secondary	Advanced colorectal neoplasm detection rate		2 years

External Links

•   Webpage of the Spanish Gastroenterological Association, which endorses COLONPREV trial