Evidence map›Paper›PMID 30442983›Full record

ArticleScientific reports2018

Clinical performance of an analytically validated assay in comparison to microarray technology to assess PITX2 DNA-methylation in breast cancer.

Gabriele Schricker, Rudolf Napieralski, Aurelia Noske, Elodie Piednoir, Olivia Manner, Elisabeth Schüren, Jürgen Lauber, Jonathan Perkins, Viktor Magdolen, Manfred Schmitt and 5 more

Open access · goldAbstract readComparative StudyValidation Study
In one paragraph

Article in Scientific reports, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.7field-weighted citation impact, top 29% 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.

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

9 citing papers in PubMed, 18 citations in OpenAlex.

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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

15 authors at 6 institutions in 4 countries.

Gabriele SchrickerTherawis Diagnostics GmbH, Grillparzerstrasse 14, 81675, Munich, Germany. gabriele.schricker@therawis.com.
Rudolf NapieralskiTherawis Diagnostics GmbH, Grillparzerstrasse 14, 81675, Munich, Germany.
Aurelia NoskeInstitute of Pathology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Strasse 22, 81675, Munich, Germany.
Elodie PiednoirHalioDx Luminy Biotech Entreprises, 163 Avenue de Luminy, 13009, Marseille, France.
Olivia MannerHalioDx Luminy Biotech Entreprises, 163 Avenue de Luminy, 13009, Marseille, France.
Elisabeth SchürenTherawis Diagnostics GmbH, Grillparzerstrasse 14, 81675, Munich, Germany.
Jürgen LauberQIAGEN GmbH, Qiagen Strasse 1, 40724, Hilden, Germany.
Jonathan PerkinsQIAGEN Manchester Ltd., Lloyd Street North, Manchester, M15 6SH, United Kingdom.
Viktor MagdolenDepartment of Obstetrics and Gynecology, Clinical Research Unit, Klinikum rechts der Isar, Technische Universität München, Ismaningerstrasse 22, 81675, Munich, Germany.
Manfred SchmittTherawis Diagnostics GmbH, Grillparzerstrasse 14, 81675, Munich, Germany.
Kurt UlmInstitute of Medical Informatics, Statistics and Epidemiology, Grillparzerstrasse 18, 81675, Munich, Germany.
Wilko WeichertInstitute of Pathology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Strasse 22, 81675, Munich, Germany.
Marion KiechleDepartment of Obstetrics and Gynecology, Clinical Research Unit, Klinikum rechts der Isar, Technische Universität München, Ismaningerstrasse 22, 81675, Munich, Germany.
John W M MartensDepartment of Medical Oncology and Cancer Genomics Netherlands, Erasmus MC, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.ORCID http://orcid.org/0000-0002-3428-3366
Olaf G WilhelmTherawis Diagnostics GmbH, Grillparzerstrasse 14, 81675, Munich, Germany.
TUM Klinikum · DECS Diagnostics · DEOZ Biosciences (France) · FRErasmus MC · NLQiagen (Germany) · DEQiagen (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Significant evidence has accumulated that DNA-methylation of the paired-like homeodomain transcription factor 2 (PITX2) gene can serve as a prognostic and predictive biomarker in breast cancer. PITX2 DNA-methylation data have been obtained so far from microarray and polymerase chain reaction (PCR)-based research tests. The availability of an analytically validated in vitro methylation-specific real-time PCR assay format (therascreen PITX2 RGQ PCR assay) intended for the determination of the percent methylation ratio (PMR) in the (PITX2) promoter 2 prompted us to investigate whether the clinical performance of these different assay systems generate comparable clinical outcome data. Mathematically converted microarray data of a previous breast cancer study (n = 204) into PMR values leads to a PITX2 cut-off value at PMR 14.73. Recalculation of the data to experimentally equivalent PMRs with the PCR PITX2 assay leads to a cut-off value at PMR 12 with the highest statistical significance. This cut-off predicts outcome of high-risk breast cancer patients to adjuvant anthracycline-based chemotherapy (n = 204; Hazard Ratio 2.48; p < 0.001) comparable to microarray generated results (n = 204; Hazard ratio 2.32; p < 0.0001). The therascreen PITX2 RGQ PCR assay is an analytically validated test with high reliability and robustness and predicts outcome of high-risk breast cancer patients to anthracycline-based chemotherapy.

Indexed as

Biological AssayBreast NeoplasmsDNA MethylationDNA, NeoplasmFemaleGenetic HeterogeneityHomeobox Protein PITX2Homeodomain ProteinsHumansKaplan-Meier EstimateMiddle AgedOligonucleotide Array Sequence AnalysisParaffin EmbeddingReproducibility of ResultsTissue FixationTranscription FactorsDNA, NeoplasmHomeobox Protein PITX2Homeodomain ProteinsTranscription Factors

Identifiers

PMID30442983
PMCPMC6237923
OpenAlexW2899708792

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.