Evidence map›Paper›PMID 27580745›Full record

ArticleBMC medicine2016

Development and external validation of a faecal immunochemical test-based prediction model for colorectal cancer detection in symptomatic patients.

Joaquín Cubiella, Pablo Vega, María Salve, Marta Díaz-Ondina, Maria Teresa Alves, Enrique Quintero, Victoria Álvarez-Sánchez, Fernando Fernández-Bañares, Jaume Boadas, Rafel Campo and 9 more

2 registry-linked trialsAbstract read
In one paragraph

Article in BMC medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07430527 recruitingnot on this mapstarted 2026, after this paper: background citation

A Retrospective Review of the Secondary-care Colorectal Cancer Pathway Within NHS Lothian: An Evaluation of 3 Years of Pathway Performance

TypeobservationalSponsorUniversity of EdinburghRan2026 to 2030Enrolled25,000ConditionsColorectal Cancer (Diagnosis)ArmsFaecal Immunohistochemical test
NCT07430540 narecruitingnot on this mapstarted 2026, after this paper: background citation

Optimising Patient Pathways for Earlier Detection of Colorectal Cancer in Secondary Care: Implementation of Multiple FIT Testing

TypeinterventionalSponsorUniversity of EdinburghRan2026 to 2037Enrolled1,000ConditionsColorectal Cancer, Significant Bowel PathologyArmsAdditional FIT testing
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  10. Colorectal Cancer: Risk Factors, Novel Approaches in Molecular Screening and Treatment.International journal of molecular and cellular medicine · 2025
    Review
  11. Faecal haemoglobin concentration and colorectal cancer site, stage and grade in a symptomatic cohort.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2024
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Joaquín CubiellaGastroenterology Department, Complexo Hospitalario Universitario de Ourense, Rua Ramón Puga 52-54, 32005, Ourense, Spain. joaquin.cubiella.fernandez@sergas.es.
Pablo VegaGastroenterology Department, Complexo Hospitalario Universitario de Ourense, Rua Ramón Puga 52-54, 32005, Ourense, Spain.
María SalveGastroenterology Department, Complexo Hospitalario Universitario de Ourense, Rua Ramón Puga 52-54, 32005, Ourense, Spain.
Marta Díaz-OndinaClinical Analysis Department, Complexo Hospitalario Universitario de Ourense, Rua Ramón Puga 52-54, 32003, Ourense, Spain.
Maria Teresa AlvesNECOM Group, University of Vigo, Campus Universitario As Lagoas, Marcosende, 36310, Vigo, Spain.
Enrique QuinteroGastroenterology Department, Hospital Universitario de Canarias, Instituto Universitario de Tecnologías Biomédicas (ITB) & Centro de Investigación Biomédica de Canarias (CIBICAN), Universidad de La Laguna, Carretera de Ofra, s/n, 38320, San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain.
Victoria Álvarez-SánchezGastroenterology Department, Complejo Hospitalario de Pontevedra, Av. Montecelo, 36164 Casas Novas, Pontevedra, Spain.
Fernando Fernández-BañaresGastroenterology Department, Hospital Universitari Mútua de Terrassa, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Plaça del Doctor Robert, 5, 08221, Terrassa, Barcelona, Spain.
Jaume BoadasGastroenterology Department, Consorci Sanitari de Terrassa, Carr. Torrebonica, S/N, 08227, Terrassa, Barcelona, Spain.
Rafel CampoGastroenterology Department, Hospital de Sabadell, Corporació Sanitària i Universitària Parc Taulí, Parc Taulí, 1, 08208, Sabadell, Barcelona, Spain.
Luis BujandaDonostia Hospital, Biodonostia Institute, University of the Basque Country UPV/EHU, (CIBERehd), Paseo del Doctor Begiristain 117, 20080, San Sebastian, Guipuzcoa, Spain.
Joan ClofentGastroenterology Department, Hospital de Sagunto, Avenida Ramón y Cajal, S/N, 46520, Sagunto, Valencia, Spain.
Ángel FerrandezServicio de Aparato Digestivo, Hospital Clínico Universitario, IIS Aragón, University of Zaragoza, (CIBERehd), Avda. San Juan Bosco, 15, 50009, Zaragoza, Spain.
Leyanira TorrealbaGastroenterology Department, Hospital Dr. Josep Trueta, Avenida de Francia, s/n, 17007, Girona, Spain.
Virginia PiñolGastroenterology Department, Hospital Dr. Josep Trueta, Avenida de Francia, s/n, 17007, Girona, Spain.
Daniel Rodríguez-AlcaldeDigestive Disease Section, Hospital Universitario de Móstoles Río Júcar, s/n, 28935, Mostoles, Madrid, Spain.
Vicent HernándezInstituto de Investigación Biomedica (IBI) Ourense, Pontevedra y Vigo, Vigo, Rua Ramón Puga 52-54, 32003, Ourense, Spain.
Javier Fernández-SearaGastroenterology Department, Complexo Hospitalario Universitario de Ourense, Rua Ramón Puga 52-54, 32005, Ourense, Spain.
COLONPREDICT study investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRisk prediction models for colorectal cancer (CRC) detection in symptomatic patients based on available biomarkers may improve CRC diagnosis. Our aim was to develop, compare with the NICE referral criteria and externally validate a CRC prediction model, COLONPREDICT, based on clinical and laboratory variables.

methodsThis prospective cross-sectional study included consecutive patients with gastrointestinal symptoms referred for colonoscopy between March 2012 and September 2013 in a derivation cohort and between March 2014 and March 2015 in a validation cohort. In the derivation cohort, we assessed symptoms and the NICE referral criteria, and determined levels of faecal haemoglobin and calprotectin, blood haemoglobin, and serum carcinoembryonic antigen before performing an anorectal examination and a colonoscopy. A multivariate logistic regression analysis was used to develop the model with diagnostic accuracy with CRC detection as the main outcome.

resultsWe included 1572 patients in the derivation cohort and 1481 in the validation cohorts, with a 13.6 % and 9.1 % CRC prevalence respectively. The final prediction model included 11 variables: age (years) (odds ratio [OR] 1.04, 95 % confidence interval [CI] 1.02-1.06), male gender (OR 2.2, 95 % CI 1.5-3.4), faecal haemoglobin ≥20 μg/g (OR 17.0, 95 % CI 10.0-28.6), blood haemoglobin <10 g/dL (OR 4.8, 95 % CI 2.2-10.3), blood haemoglobin 10-12 g/dL (OR 1.8, 95 % CI 1.1-3.0), carcinoembryonic antigen ≥3 ng/mL (OR 4.5, 95 % CI 3.0-6.8), acetylsalicylic acid treatment (OR 0.4, 95 % CI 0.2-0.7), previous colonoscopy (OR 0.1, 95 % CI 0.06-0.2), rectal mass (OR 14.8, 95 % CI 5.3-41.0), benign anorectal lesion (OR 0.3, 95 % CI 0.2-0.4), rectal bleeding (OR 2.2, 95 % CI 1.4-3.4) and change in bowel habit (OR 1.7, 95 % CI 1.1-2.5). The area under the curve (AUC) was 0.92 (95 % CI 0.91-0.94), higher than the NICE referral criteria (AUC 0.59, 95 % CI 0.55-0.63; p < 0.001). On the basis of the thresholds with 90 % (5.6) and 99 % (3.5) sensitivity, we divided the derivation cohort into three risk groups for CRC detection: high (30.9 % of the cohort, positive predictive value [PPV] 40.7 %, 95 % CI 36.7-45.9 %), intermediate (29.5 %, PPV 4.4 %, 95 % CI 2.8-6.8 %) and low (39.5 %, PPV 0.2 %, 95 % CI 0.0-1.1 %). The discriminatory ability was equivalent in the validation cohort (AUC 0.92, 95 % CI 0.90-0.94; p = 0.7).

conclusionsCOLONPREDICT is a highly accurate prediction model for CRC detection.

Indexed as

Colorectal NeoplasmsFecesAgedBiomarkersCarcinoembryonic AntigenColonoscopyCross-Sectional StudiesEarly Detection of CancerFemaleHemoglobinsHumansImmunochemistryLeukocyte L1 Antigen ComplexMaleModels, TheoreticalPredictive Value of TestsBiomarkersCarcinoembryonic AntigenHemoglobinsLeukocyte L1 Antigen ComplexColonoscopyColorectal cancerDiagnostic accuracyFaecal immunochemical testPrompt diagnosisRisk stratification

Identifiers

PMID27580745
PMCPMC5007726

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.