Evidence map›Paper›PMID 26314581›Full record

Trial reportBMC cancer2015

Positive family history of colorectal cancer in a general practice setting [FRIDA.Frankfurt]: study protocol of a of a cross-sectional study.

Andrea Siebenhofer, Jasper Plath, Maja Taubenroth, Susanne Singer, Marlene Hechtner, Anne Dahlhaus, Sandra Rauck, Sylvia Schulz-Rothe, Insa Koné, Ferdinand M Gerlach

Abstract readClinical Trial
In one paragraph

Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Andrea SiebenhoferInstitute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. siebenhofer@allgemeinmedizin.uni-frankfurt.de.
Jasper PlathInstitute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. j.plath@dkfz-heidelberg.de.
Maja TaubenrothInstitute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. taubenroth@allgemeinmedizin.uni-frankfurt.de.
Susanne SingerGerman Cancer Research Center (DKFZ), Heidelberg, Germany. singers@uni-mainz.de.
Marlene HechtnerGerman Cancer Research Center (DKFZ), Heidelberg, Germany. m.hechtner@dkfz-heidelberg.de.
Anne DahlhausInstitute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. a.dahlhaus@dkfz-heidelberg.de.
Sandra RauckInstitute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. rauck@allgemeinmedizin.uni-frankfurt.de.
Sylvia Schulz-RotheInstitute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. schulz-rothe@allgemeinmedizin.uni-frankfurt.de.
Insa KonéInstitute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. kone@allgemeinmedizin.uni-frankfurt.de.
Ferdinand M GerlachInstitute of General Practice, Goethe-University Frankfurt, Frankfurt am Main, Germany. gerlach@allgemeinmedizin.uni-frankfurt.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough the risk of developing colorectal cancer (CRC) is 2-4 times higher in case of a positive family history, risk-adapted screening programs for family members related to CRC- patients do not exist in the German health care system. CRC screening recommendations for persons under 55 years of age that have a family predisposition have been published in several guidelines. The primary aim of this study is to determine the frequency of positive family history of CRC (1st degree relatives with CRC) among 40-54 year old persons in a general practitioner (GP) setting in Germany. Secondary aims are to detect the frequency of occurrence of colorectal neoplasms (CRC and advanced adenomas) in 1st degree relatives of CRC patients and to identify the variables (e.g. demographic, genetic, epigenetic and proteomic characteristics) that are associated with it. This study also explores whether evidence-based information contributes to informed decisions and how screening participation correlates with anxiety and (anticipated) regret. METHODS/

designPrior to the beginning of the study, the GP team (GP and one health care assistant) in around 50 practices will be trained, and about 8,750 persons that are registered with them will be asked to complete the "Network against colorectal cancer" questionnaire. The 10% who are expected to have a positive family history will then be invited to give their informed consent to participate in the study. All individuals with positive family history will be provided with evidence-based information and prevention strategies. We plan to examine each participant's family history of CRC in detail and to collect information on further variables (e.g. demographics) associated with increased risk. Additional stool and blood samples will be collected from study-participants who decide to undergo a colonoscopy (n ~ 350) and then analyzed at the German Cancer Research Center (DKFZ) Heidelberg to see whether further relevant variables are associated with an increased risk of CRC. One screening list and four questionnaires will be used to collect the data, and a detailed statistical analysis plan will be provided before the database is closed (expected to be June 30, 2015). DISCUSSION: It is anticipated that when persons with a family history of colorectal cancer have been provided with professional advice by the practice team, there will be an increase in the availability of valid information on the frequency of affected individuals and an increase in the number of persons making informed decisions. We also expect to identify further variables that are associated with colorectal cancer. This study therefore has translational relevance from lab to practice.

trial registrationGerman Clinical Trials Register DRKS00006277.

Indexed as

Family HealthAdenomaAdultColonoscopyColorectal NeoplasmsCross-Sectional StudiesEarly Detection of CancerGeneral PracticeGermanyHealth SurveysHumansMiddle AgedOccult BloodPhysician-Patient RelationsPreventive MedicineResearch Design

Identifiers

PMID26314581
PMCPMC4552264

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.