title: Daily clinical practice of fresh tumour tissue freezing and gene expression profiling; logistics pilot study preceding the MINDACT trial.
abstract: OBJECTIVE
  The 70-gene prognosis-signature is a prognostic tool for early breast cancer analysis. In addition to scientific evidence, implementation of the signature in clinical trials and daily practice requires logistical feasibility. The aim of our study was to test logistics for gene expression profiling on fresh frozen tumour tissue in the preparation for the prospective, multinational Microarray In Node-negative Disease may Avoid ChemoTherapy (MINDACT) trial.
  
  
  METHODS
  Sixty-four patients were included in six European hospitals. Fresh frozen tumour samples were shipped on dry ice to Agendia B.V., where RNA was isolated and subsequently hybridised on the 70-gene prognosis-signature (MammaPrint).
  
  
  RESULTS
  Tumour samples were obtained in 60 of 64 patients. Among the 60 samples, 11 contained insufficient tumour cells (<50%) and three contained insufficient RNA quality. All 46 samples eligible for genomic profiling were successfully hybridised, and the results were reported on average within 4-5d.
  
  
  CONCLUSIONS
  Gene expression profiling on fresh frozen tissue is feasible in daily clinical practice.
authors.affiliation: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Division of Pathology and Surgical Oncology, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands.
authors.forename: S
authors.initials: S
authors.lastname: Mook
authors.affiliation: Geneva University Hospitals, Geneva, Switzerland.
authors.forename: H
authors.initials: H
authors.lastname: Bonnefoi
authors.affiliation: European Institute of Oncology, University of Milan, Milan, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Pruneri
authors.affiliation: Institute Jules Bordet, Brussels, Belgium.
authors.forename: D
authors.initials: D
authors.lastname: Larsimont
authors.affiliation: Medical University of Gdansk, Gdansk, Poland.
authors.forename: J
authors.initials: J
authors.lastname: Jaskiewicz
authors.affiliation: Vall d'Hebron University Hospital, Barcelona, Spain.
authors.forename: M D
authors.initials: MD
authors.lastname: Sabadell
authors.affiliation: Institute Bergonié, Bordeaux, France.
authors.forename: G
authors.initials: G
authors.lastname: MacGrogan
authors.affiliation: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Division of Pathology and Surgical Oncology, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands; Agendia B.V., Amsterdam, The Netherlands.
authors.forename: L J
authors.initials: LJ
authors.lastname: Van't Veer
authors.affiliation: Institute Jules Bordet, Brussels, Belgium.
authors.forename: F
authors.initials: F
authors.lastname: Cardoso
authors.affiliation: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Division of Pathology and Surgical Oncology, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands. Electronic address: e.rutgers@nki.nl.
authors.forename: E J
authors.initials: EJ
authors.lastname: Rutgers
mesh_terms: D000368:Aged; D014408:Biomarkers, Tumor / Q000235:genetics*; D001943:Breast Neoplasms / Q000235:genetics / Q000473:pathology; D018270:Carcinoma, Ductal, Breast / Q000235:genetics / Q000473:pathology; D002986:Clinical Trials as Topic; D015925:Cryopreservation / Q000379:methods / Q000592:standards*; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D020869:Gene Expression Profiling; D006801:Humans; D016015:Logistic Models; D008875:Middle Aged; D020411:Oligonucleotide Array Sequence Analysis; D010865:Pilot Projects; D013048:Specimen Handling / Q000379:methods / Q000592:standards*
chemical_list: D014408:Biomarkers, Tumor