title: Cancer and Leukemia Group B Pathology Committee guidelines for tissue microarray construction representing multicenter prospective clinical trial tissues.
abstract: Practice-changing evidence requires confirmation, preferably in multi-institutional clinical trials. The collection of tissue within such trials has enabled biomarker studies and evaluation of companion diagnostic tests. Tissue microarrays (TMAs) have become a standard approach in many cooperative oncology groups. A principal goal is to maximize the number of assays with this precious tissue. However, production strategies for these arrays have not been standardized, possibly decreasing the value of the study. In this article, members of the Cancer and Leukemia Group B Pathology Committee relay our experiences as array facility directors and propose guidelines regarding the production of high-quality TMAs for cooperative group studies. We also discuss statistical issues arising from having a proportion of patients available for TMAs and the possibility that patients with TMAs fail to represent the greater study population.
authors.affiliation: Yale University School of Medicine, New Haven, CT 06520-8023, USA. david.rimm@yale.edu
authors.forename: David L
authors.initials: DL
authors.lastname: Rimm
authors.forename: Torsten O
authors.initials: TO
authors.lastname: Nielsen
authors.forename: Scott D
authors.initials: SD
authors.lastname: Jewell
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Rohrer
authors.forename: Gloria
authors.initials: G
authors.lastname: Broadwater
authors.forename: Frederic
authors.initials: F
authors.lastname: Waldman
authors.forename: Kisha A
authors.initials: KA
authors.lastname: Mitchell
authors.forename: Baljit
authors.initials: B
authors.lastname: Singh
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Tsongalis
authors.forename: Wendy L
authors.initials: WL
authors.lastname: Frankel
authors.forename: Anthony M
authors.initials: AM
authors.lastname: Magliocco
authors.forename: Jonathan F
authors.initials: JF
authors.lastname: Lara
authors.forename: Eric D
authors.initials: ED
authors.lastname: Hsi
authors.forename: Ira J
authors.initials: IJ
authors.lastname: Bleiweiss
authors.forename: Sunil S
authors.initials: SS
authors.lastname: Badve
authors.forename: Beiyun
authors.initials: B
authors.lastname: Chen
authors.forename: Peter M
authors.initials: PM
authors.lastname: Ravdin
authors.forename: Richard L
authors.initials: RL
authors.lastname: Schilsky
authors.forename: Ann
authors.initials: A
authors.lastname: Thor
authors.forename: Donald A
authors.initials: DA
authors.lastname: Berry
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis*; D002986:Clinical Trials as Topic; D006801:Humans; D015337:Multicenter Studies as Topic; D013048:Specimen Handling / Q000379:methods; D046888:Tissue Array Analysis / Q000379:methods*
chemical_list: D014408:Biomarkers, Tumor