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Colorectal CancerNCT00906997

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

A study testing Immunochemical fecal occult blood test and Colonoscopy in people with Colorectal Cancer and Colorectal Neoplasm, run by Hospital Clinic of Barcelona at 8 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 69 years
Conditions the study is for
Colorectal Cancer, Colorectal Neoplasm
What is being tested?
Immunochemical fecal occult blood test and Colonoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55,498 participants
Where
8 sitesSpain
Study dates
Nov 2008to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women aged 50-69 years

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Spain8 sites

  • Hospital del Mar

    Barcelona

  • Hospital Clínico

    Madrid

  • Hospital Universitario Virgen de la Arrixaca

    Murcia

  • Hospital Meixoeiro

    Ourense

  • Hospital de Donosti

    San Sebastián

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife

  • Comunidad Valencia

    Valencia

  • Hospital Clínico Lozano Blesa

    Zaragoza

Other trials in Spain

About this study

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

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).

Being tested
Immunochemical fecal occult blood test, Colonoscopy
Keywords
Colorectal cancer, Screening, Prevention, Fecal occult blood test, Colonoscopy, Colorectal neoplasm, Randomized clinical trial
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immunochemical fecal occult blood testProcedure or surgery

    Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.

  • ColonoscopyProcedure or surgery

    Every 10 years, with sedation.

Study groups in NCT00906997
Study groupRoleWhat they receive
Fecal occult blood testingActive comparatorFecal immunochemical testing biennially
Receives: Procedure: Immunochemical fecal occult blood test
ColonoscopyActive comparatorColonoscopy one time
Receives: Procedure: Colonoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Colorectal cancer-related mortality

    Measured: 10 years

Secondary outcomes (5)

  1. Compliance rate

    Measured: 2 years

  2. Complication rate

    Measured: 10 years

  3. Colorectal cancer incidence

    Measured: 15 years

  4. Adherence rate

    Measured: 10 years

  5. Advanced colorectal neoplasm detection rate

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2009 (estimated)
  2. Study startNov 2008
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55,498 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00906997
Sponsor's protocol ID
COLONPREV
Status last verified
Mar 2025
First submitted
19 May 2009
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Cubiella J, Garcia-Benito C, Castells A, Quintero E, Bujanda L, Castan-Cameo S, Diaz-Tasende J, Lanas A, Ono A, Frias-Arrocha E, Hernandez C, Jover R, Andreu M, Carballo F, Morillas JD, Salas D, Regueiro-Exposito C, Davila-Pinon P, Diez-Martin A; COLONPREV study investigators. Long-Term Colorectal Cancer Incidence After Adenoma and Serrated Polyp Removal: Results From the Colonprev Trial. United European Gastroenterol J. 2026 Jun;14(5):e70245. doi: 10.1002/ueg2.70245.

    PubMed 42272346

  • Castells A, Quintero E, Chen H, Bujanda L, Castan-Cameo S, Cubiella J, Diaz-Tasende J, Lanas A, Ono A, Serra-Burriel M; COLONPREV Study Investigators. Colonoscopy versus biennial FIT screening: a post hoc sustained-strategy analysis of the COLONPREV Trial. Gut. 2026 Jun 10:gutjnl-2026-338896. doi: 10.1136/gutjnl-2026-338896. Online ahead of print.

    PubMed 42270316

  • Castells A, Quintero E, Serra-Burriel M, Bujanda L, Castan-Cameo S, Cubiella J, Diaz-Tasende J, Lanas A, Ono A, Coll-Vinent B, Frias-Arrocha E, Hernandez C, Jover R, Andreu M, Carballo F, Morillas JD, Salas D; COLONPREV study investigators. Sex- and Age-Stratified Outcomes of Colonoscopy Versus Faecal Immunochemical Testing: Post-Analysis of the COLONPREV Study. United European Gastroenterol J. 2026 Mar;14(2):e70169. doi: 10.1002/ueg2.70169.

    PubMed 41715250

  • Castells A, Quintero E, Bujanda L, Castan-Cameo S, Cubiella J, Diaz-Tasende J, Lanas A, Ono A, Serra-Burriel M, Frias-Arrocha E, Hernandez C, Jover R, Andreu M, Carballo F, Morillas JD, Salas D, Almazan R, Alonso-Abreu I, Banales JM, Hernandez V, Portillo I, Vanaclocha-Espi M, de la Vega M; COLONPREV study investigators. Effect of invitation to colonoscopy versus faecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial. Lancet. 2025 Apr 12;405(10486):1231-1239. doi: 10.1016/S0140-6736(25)00145-X. Epub 2025 Mar 27.

    PubMed 40158525

  • Shaukat A, Kahi CJ, Burke CA, Rabeneck L, Sauer BG, Rex DK. ACG Clinical Guidelines: Colorectal Cancer Screening 2021. Am J Gastroenterol. 2021 Mar 1;116(3):458-479. doi: 10.14309/ajg.0000000000001122.

    PubMed 33657038

  • Salas D, Vanaclocha M, Ibanez J, Molina-Barcelo A, Hernandez V, Cubiella J, Zubizarreta R, Andreu M, Hernandez C, Perez-Riquelme F, Cruzado J, Carballo F, Bujanda L, Sarasqueta C, Portillo I, de la Vega-Prieto M, Morillas JD, Valentin V, Lanas A, Quintero E, Castells A. Participation and detection rates by age and sex for colonoscopy versus fecal immunochemical testing in colorectal cancer screening. Cancer Causes Control. 2014 Aug;25(8):985-97. doi: 10.1007/s10552-014-0398-y. Epub 2014 May 24.

    PubMed 24859111

  • Castells A, Quintero E, Alvarez C, Bujanda L, Cubiella J, Salas D, Lanas A, Carballo F, Morillas JD, Hernandez C, Jover R, Hijona E, Portillo I, Enriquez-Navascues JM, Hernandez V, Martinez-Turnes A, Menendez-Villalva C, Gonzalez-Mao C, Sala T, Ponce M, Andres M, Teruel G, Peris A, Sopena F, Gonzalez-Rubio F, Seoane-Urgorri A, Grau J, Serradesanferm A, Pozo A, Pellise M, Balaguer F, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, Carrillo-Palau M, de la Vega-Prieto M, Iglesias R, Amador J, Blanco JM, Sastre R, Ferrandiz J, Gonzalez-Hernandez MJ, Andreu M, Bessa X; COLONPREV Study Investigators. Rate of detection of advanced neoplasms in proximal colon by simulated sigmoidoscopy vs fecal immunochemical tests. Clin Gastroenterol Hepatol. 2014 Oct;12(10):1708-16.e4. doi: 10.1016/j.cgh.2014.03.022. Epub 2014 Mar 27.

    PubMed 24681078

  • Hernandez V, Cubiella J, Gonzalez-Mao MC, Iglesias F, Rivera C, Iglesias MB, Cid L, Castro I, de Castro L, Vega P, Hermo JA, Macenlle R, Martinez-Turnes A, Martinez-Ares D, Estevez P, Cid E, Vidal MC, Lopez-Martinez A, Hijona E, Herreros-Villanueva M, Bujanda L, Rodriguez-Prada JI; COLONPREV Study Investigators. Fecal immunochemical test accuracy in average-risk colorectal cancer screening. World J Gastroenterol. 2014 Jan 28;20(4):1038-47. doi: 10.3748/wjg.v20.i4.1038.

    PubMed 24574776

  • Bujanda L, Lanas A, Quintero E, Castells A, Sarasqueta C, Cubiella J, Hernandez V, Morillas JD, Perez-Fernandez T, Salas D, Andreu M, Carballo F, Bessa X, Cosme A, Jover R; COLONPREV Study Investigators. Effect of aspirin and antiplatelet drugs on the outcome of the fecal immunochemical test. Mayo Clin Proc. 2013 Jul;88(7):683-9. doi: 10.1016/j.mayocp.2013.04.016. Epub 2013 Jun 7.

    PubMed 23751980

  • 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.

    PubMed 22356323

Questions about this trial

What is this clinical trial studying?

A study testing Immunochemical fecal occult blood test and Colonoscopy in people with Colorectal Cancer and Colorectal Neoplasm, run by Hospital Clinic of Barcelona at 8 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Colorectal cancer-related mortality (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00906997, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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