ArticleVirchows Archiv : an international journal of pathology2014
Preanalytical variables and performance of diagnostic RNA-based gene expression analysis in breast cancer.
Article in Virchows Archiv : an international journal of pathology, 2014. 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 10 papers.
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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.
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.
Prospective Assessment of Disease Progression in Primary Breast Cancer Patients Undergoing EndoPredict® Gene Expression Testing - a Care Research Study
French Prospective Real-life Evaluation of the Endopredict® Genomic Signature for HR-positive,HER2-negative Early Breast Cancer
Who cites it
10 citing papers in PubMed.
- Use of Automated BaseScope Assay on the Leica BOND RX.Methods in molecular biology (Clifton, N.J.) · 2026Article
- Real-life data from standardized preanalytical coding (SPREC) in tissue biobanking and its dual use for sample characterization and process optimization.The journal of pathology. Clinical research · 2023Article
- Quality Considerations When Using Tissue Samples for Biomarker Studies in Cancer Research.Biomarker insights · 2021Article
- Impact of different stabilization methods on RT-qPCR results using human lung tissue samples.Scientific reports · 2020Article
- Cold Ischemia Score: An mRNA Assay for the Detection of Extended Cold Ischemia in Formalin-Fixed, Paraffin-Embedded Tissue.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2019Article
- Small Nucleolar RNA Score: An Assay to Detect Formalin-Overfixed Tissue.Biopreservation and biobanking · 2018Article
- Robustness of biomarker determination in breast cancer by RT-qPCR: impact of tumor cell content, DCIS and non-neoplastic breast tissue.Diagnostic pathology · 2018Article
- Understanding preanalytical variables and their effects on clinical biomarkers of oncology and immunotherapy.Seminars in cancer biology · 2018Review
- Analytical validation of a 12-gene molecular test for the prediction of distant recurrence in breast cancer.Future science OA · 2017Article
- [Molecular pathology for breast cancer: Importance of the gene expression profile].Der Pathologe · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Prognostic multigene expression assays have become widely available to provide additional information to standard clinical parameters and to support clinicians in treatment decisions. In this study, we analyzed the impact of variations in tissue handling on the diagnostic EndoPredict test results. EndoPredict is a quantitative reverse transcription PCR assay conducted on RNA from formalin-fixed, paraffin-embedded (FFPE) tissue that predicts the likelihood of distant recurrence in patients with ER-positive/HER2-negative breast cancer. In this study, we performed a total of 138 EndoPredict assays to study the effects of preanalytical variables such as time to fixation, fixation time, tumor cell content, and section storage time on the EndoPredict test results. A time to fixation of up to 12 h and fixation of up to 5 days did not affect the results of the gene expression test. Paired samples of FFPE sections with tumor cell content ranging from 15 to 95 % and tumor-enriched samples showed a correlation coefficient of 0.97. Test results of tissue sections that have been stored for 12 months at +4 or +20 °C showed a correlation of 0.99 when compared to results of nonstored sections. In conclusion, preanalytical tissue handling is not a critical factor for diagnostic gene expression analysis with the EndoPredict assay. The test can therefore be easily integrated into the standard workflow of molecular pathology.
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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.