Evidence map›Paper›PMID 15306594›Full record

Trial reportGut2004

Testing for faecal calprotectin (PhiCal) in the Norwegian Colorectal Cancer Prevention trial on flexible sigmoidoscopy screening: comparison with an immunochemical test for occult blood (FlexSure OBT).

G Hoff, T Grotmol, E Thiis-Evensen, M Bretthauer, G Gondal, M H Vatn

Registry-linked trialAbstract readClinical TrialComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Gut, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00119912 (Norwegian Colorectal Cancer Prevention Trial), which is not on this map. Cited by 24 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 5 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.

NCT00119912 naactive not recruitingnot on this map

Norwegian Colorectal Cancer Prevention Trial

TypeinterventionalSponsorNorwegian Institute of Public HealthRan1999 to 2036Enrolled100,000ConditionsColorectal Cancer, AdenomaArmsA 1 Intervention arm Flex Sig, A 2 Intervention arm Flex Sig + iFOBT
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Diagnostic accuracy of fecal calprotectin for screening patients with colorectal cancer: A meta-analysis.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2018
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Article
  9. Article
  10. Early detection: the impact of genomics.Virchows Archiv : an international journal of pathology · 2017
    Review
  11. Advances in Fecal Tests for Colorectal Cancer Screening.Current treatment options in gastroenterology · 2016
    Article
  12. Review
  13. Fecal calprotectin in inflammatory bowel disease.Clinical and experimental gastroenterology · 2016
    Review
  14. Fecal calprotectin use in inflammatory bowel disease and beyond: A mini-review.Canadian journal of gastroenterology & hepatology · 2015
    Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Article
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

6 authors.

G HoffThe Cancer Registry of Norway, Montebello, N-0310 Oslo, Norway. hofg@online.no
T Grotmol
E Thiis-Evensen
M Bretthauer
G Gondal
M H Vatn

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundScreening for colorectal cancer (CRC) using guaiac based faecal occult blood tests (FOBT) has an estimated programme sensitivity of >60% but <30% for strictly asymptomatic CRC in a single screening round. In search for improved non-invasive tests for screening, we compared a test for faecal calprotectin (PhiCal) with a human haemoglobin immunochemical FOBT (FlexSure OBT).

methodsIn the Norwegian Colorectal Cancer Prevention (NORCCAP) trial, screenees in one screening arm were offered screening with combined flexible sigmoidoscopy (FS) and FlexSure OBT. They were also requested to bring a fresh frozen sample of stool for the PhiCal test which was performed on samples from screenees with CRC (n = 16), high risk adenoma (n = 195), low risk adenoma (n = 592), and no adenoma (n = 1518) (2321 screenees in total). A positive PhiCal test was defined by a calprotectin level > or =50 microg/g.

resultsThe PhiCal test was positive in 24-27% of screenees whether they had no adenoma, low risk adenoma, or high risk adenoma. Ten (63%) of 16 CRCs gave a positive PhiCal test. The total positivity rate in this population was 25% for the PhiCal test compared with 12% for FlexSure OBT, with a sensitivity for advanced neoplasia of 27% and 35%, respectively. Specificity for "any neoplasia" was 76% for the PhiCal test and 90% for FlexSure OBT.

conclusionsIn colorectal screening, the performance of the PhiCal test on a single spot from one stool sample was poorer than a single screening round with FlexSure OBT and cannot be recommended for population screening purposes. The findings indicate a place for FlexSure OBT in FOBT screening.

Indexed as

AdenomaBiomarkers, TumorColorectal NeoplasmsFecesFemaleHumansLeukocyte L1 Antigen ComplexMaleMass ScreeningMiddle AgedNeoplasm ProteinsOccult BloodSensitivity and SpecificitySigmoidoscopyBiomarkers, TumorLeukocyte L1 Antigen ComplexNeoplasm Proteins

Identifiers

PMID15306594
PMCPMC1774205

What OpenQuestion holds

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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.