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. 2020 Jan 2;153(2):149-155.
doi: 10.1093/ajcp/aqz141.

Toward Improving Practices for Submission of Diagnostic Tissue Blocks for National Cancer Institute Clinical Trials

Hala Makhlouf  1 , Mark A Watson  2 , Heather A Lankes  3 , Carol Weil  1 , Maura Dickler  4 , Michael Birrer  5 , Christopher Moskaluk  6 , Nilsa C Ramirez  3 , Nader Okby  7 , Edgar Alonsozana  8 , Mark Barnes  9 , Edward B Goldman  10 , Rebecca Enos  11 , Irina Lubensky  1
Affiliations

Toward Improving Practices for Submission of Diagnostic Tissue Blocks for National Cancer Institute Clinical Trials

Hala Makhlouf et al. Am J Clin Pathol. .

Abstract

Objectives: The National Cancer Institute (NCI) National Clinical Trials Network performs phase II and III clinical trials, which increasingly rely on the submission of diagnostic formalin-fixed, paraffin-embedded tissue blocks for biomarker assessment. Simultaneously, advances in precision oncology require that clinical centers maintain diagnostic specimens for ancillary, standard-of-care diagnostics. This has caused tissue blocks to become a limited resource for advancing the NCI clinical trial enterprise and the practice of modern molecular pathology.

Methods: The NCI convened a 1-day workshop of multidisciplined experts to discuss barriers and strategic solutions to facilitate diagnostic block submission for clinical trial science, from the perspective of patient advocates, legal experts, pathologists, and clinical oncologists.

Results: The expert views and opinions were carefully noted and reported.

Conclusions: Recommendations were proposed to reduce institutional barriers and to assist organizations in developing clear policies regarding diagnostic block submission for clinical trials.

Keywords: Biobanks; Cancer; Clinical trials; FFPE blocks; NCTN; Oncology; Pathology; Policy.

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References

    1. Fitzgibbons PL. Are there barriers to the release of paraffin blocks for clinical research trials? A College of American Pathologists survey of 609 laboratories. Arch Pathol Lab Med. 2011;135:870-873. - PubMed
    1. National Cancer Institute. NCTN: NCI’s National Clinical Trials Network https://www.cancer.gov/research/areas/clinical-trials/nctn. Updated April 3, 2018. Accessed September 6, 2018.
    1. Camp RL, Charette LA, Rimm DL. Validation of tissue microarray technology in breast carcinoma. Lab Invest. 2000;80:1943-1949. - PubMed
    1. Specht K, Richter T, Müller U, et al. . Quantitative gene expression analysis in microdissected archival formalin-fixed and paraffin-embedded tumor tissue. Am J Pathol. 2001;158:419-429. - PMC - PubMed
    1. Cronin M, Pho M, Dutta D, et al. . Measurement of gene expression in archival paraffin-embedded tissues: development and performance of a 92-gene reverse transcriptase-polymerase chain reaction assay. Am J Pathol. 2004;164:35-42. - PMC - PubMed