Evidence map›Paper›PMID 23497601›Full record

Trial reportTrials2013

Screening for colorectal cancer with FOBT, virtual colonoscopy and optical colonoscopy: study protocol for a randomized controlled trial in the Florence district (SAVE study).

Lapo Sali, Grazia Grazzini, Francesca Carozzi, Guido Castiglione, Massimo Falchini, Beatrice Mallardi, Paola Mantellini, Leonardo Ventura, Daniele Regge, Marco Zappa and 2 more

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01651624 (Comparison Between Faecal Occult Blood Test), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
3.1field-weighted citation impact, top 8% of its field
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.

NCT01651624 nacompletednot on this map

Comparison Between Faecal Occult Blood Test (FOBT), Computed Tomographic Colonography (CTC) With Computer Aided Diagnosis (CAD) and Colonoscopy as a Primary Screening Test for Colorectal Cancer. Validation of a Teleradiology Model. Biological Banking in Subjects Recruited for Colonoscopy or CTC.

TypeinterventionalSponsorCancer Prevention and Research Institute, ItalyRan2012 to 2018Enrolled16,087ConditionsColorectal CancerArmsInvitation to screening
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Cost analysis of colorectal cancer screening with CT colonography in Italy.The European journal of health economics : HEPAC : health economics in prevention and care · 2018
    Article
  8. Review
  9. Review
  10. ESR Position Paper on Imaging Biobanks.Insights into imaging · 2015
    Article
  11. Familial colorectal cancer screening: When and what to do?World journal of gastroenterology · 2015
    Review
  12. Review
  13. Article
  14. Review
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

12 authors at 3 institutions in 1 country.

Lapo SaliRadiodiagnostic Section, Department of Clinical Physiopathology, University of Florence, Viale G, Pieraccini 6, 50139 Florence, Italy.
Grazia Grazzini
Francesca Carozzi
Guido Castiglione
Massimo Falchini
Beatrice Mallardi
Paola Mantellini
Leonardo Ventura
Daniele Regge
Marco Zappa
Mario Mascalchi
Stefano Milani
Piedmont Reference Center for Epidemiology and Cancer Prevention · ITUniversity of Florence · ITCandiolo Cancer Institute · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundColorectal cancer (CRC) is the most frequent cancer in Europe. Randomized clinical trials demonstrated that screening with fecal occult blood test (FOBT) reduces mortality from CRC. Accordingly, the European Community currently recommends population-based screening with FOBT. Other screening tests, such as computed tomography colonography (CTC) and optical colonoscopy (OC), are highly accurate for examining the entire colon for adenomas and CRC. Acceptability represents a critical determinant of the impact of a screening program. We designed a randomized controlled trial to compare participation rate and diagnostic yield of FOBT, CTC with computer-aided diagnosis, and OC as primary tests for population-based screening. METHODS/

designA total of 14,000 subjects aged 55 to 64 years, living in the Florence district and never screened for CRC, will be randomized in three arms: group 1 (5,000 persons) invited to undergo CTC (divided into: subgroup 1A with reduced cathartic preparation and subgroup 1B with standard bowel preparation); group 2 (8,000 persons) invited to undergo a biannual FOBT for three rounds; and group 3 (1,000 persons) invited to undergo OC. Subjects of each group will be invited by mail to undergo the selected test. All subjects with a positive FOBT or CTC test (that is, mass or at least one polyp ≥ 6 mm) will be invited to undergo a second-level OC. Primary objectives of the study are to compare the participation rate to FOBT, CTC and OC; to compare the detection rate for cancer or advanced adenomas of CTC versus three rounds of biannual FOBT; to evaluate referral rate for OC induced by primary CTC versus three rounds of FOBT; and to estimate costs of the three screening strategies. A secondary objective of the study is to create a biological bank of blood and stool specimens from subjects undergoing CTC and OC. DISCUSSION: This study will provide information about participation/acceptability, diagnostic yield and costs of screening with CTC in comparison with the recommended test (FOBT) and OC.

trial registrationClinicalTrials.gov Identifier: NCT01651624.

Indexed as

Colonography, Computed TomographicColonoscopyOccult BloodResearch DesignAdenomaBiological Specimen BanksClinical ProtocolsColorectal NeoplasmsCosts and Cost AnalysisHealth Care CostsHumansItalyMass ScreeningMiddle AgedPatient Acceptance of Health CarePredictive Value of Tests

Identifiers

PMID23497601
PMCPMC3618219
OpenAlexW2015866548

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.