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

Hala Makhlouf; Mark A. Watson; Heather A. Lankes; Carol Weil; Maura Dickler; Michael Birrer; Christopher Moskaluk; Nilsa C. Ramirez; Nader Okby; Edgar Alonsozana; Mark Barnes; Edward B. Goldman; Rebecca Enos; Irina Lubensky

doi:10.1093/ajcp/aqz141

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

Hala Makhlouf^*, Mark A. Watson, Heather A. Lankes, Carol Weil, Maura Dickler, Michael Birrer, Christopher Moskaluk, Nilsa C. Ramirez, Nader Okby, Edgar Alonsozana, Mark Barnes, Edward B. Goldman, Rebecca Enos, Irina Lubensky

^*Corresponding author for this work

Research output: Contribution to journal › Review article › peer-review

8 Scopus citations

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.

Original language	English
Pages (from-to)	149-155
Number of pages	7
Journal	American Journal of Clinical Pathology
Volume	153
Issue number	2
DOIs	https://doi.org/10.1093/ajcp/aqz141
State	Published - 2 Jan 2020
Externally published	Yes

Keywords

Biobanks
Cancer
Clinical trials
FFPE blocks
NCTN
Oncology
Pathology
Policy

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10.1093/ajcp/aqz141

Cite this

Makhlouf, H., Watson, M. A., Lankes, H. A., Weil, C., Dickler, M., Birrer, M., Moskaluk, C., Ramirez, N. C., Okby, N., Alonsozana, E., Barnes, M., Goldman, E. B., Enos, R., & Lubensky, I. (2020). Toward Improving Practices for Submission of Diagnostic Tissue Blocks for National Cancer Institute Clinical Trials. American Journal of Clinical Pathology, 153(2), 149-155. https://doi.org/10.1093/ajcp/aqz141

@article{038d2222742e44f39292996569161499,

title = "Toward Improving Practices for Submission of Diagnostic Tissue Blocks for National Cancer Institute Clinical Trials",

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",

author = "Hala Makhlouf and Watson, {Mark A.} and Lankes, {Heather A.} and Carol Weil and Maura Dickler and Michael Birrer and Christopher Moskaluk and Ramirez, {Nilsa C.} and Nader Okby and Edgar Alonsozana and Mark Barnes and Goldman, {Edward B.} and Rebecca Enos and Irina Lubensky",

note = "Publisher Copyright: {\textcopyright} 2019 American Society for Clinical Pathology, 2019.",

year = "2020",

month = jan,

day = "2",

doi = "10.1093/ajcp/aqz141",

language = "English",

volume = "153",

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journal = "American Journal of Clinical Pathology",

issn = "0002-9173",

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Makhlouf, H, Watson, MA, Lankes, HA, Weil, C, Dickler, M, Birrer, M, Moskaluk, C, Ramirez, NC, Okby, N, Alonsozana, E, Barnes, M, Goldman, EB, Enos, R & Lubensky, I 2020, 'Toward Improving Practices for Submission of Diagnostic Tissue Blocks for National Cancer Institute Clinical Trials', American Journal of Clinical Pathology, vol. 153, no. 2, pp. 149-155. https://doi.org/10.1093/ajcp/aqz141

TY - JOUR

T1 - Toward Improving Practices for Submission of Diagnostic Tissue Blocks for National Cancer Institute Clinical Trials

AU - Makhlouf, Hala

AU - Watson, Mark A.

AU - Lankes, Heather A.

AU - Weil, Carol

AU - Dickler, Maura

AU - Birrer, Michael

AU - Moskaluk, Christopher

AU - Ramirez, Nilsa C.

AU - Okby, Nader

AU - Alonsozana, Edgar

AU - Barnes, Mark

AU - Goldman, Edward B.

AU - Enos, Rebecca

AU - Lubensky, Irina

PY - 2020/1/2

Y1 - 2020/1/2

N2 - 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.

AB - 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.

KW - Biobanks

KW - Cancer

KW - Clinical trials

KW - FFPE blocks

KW - NCTN

KW - Oncology

KW - Pathology

KW - Policy

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U2 - 10.1093/ajcp/aqz141

DO - 10.1093/ajcp/aqz141

M3 - Review article

C2 - 31613330

AN - SCOPUS:85077404525

SN - 0002-9173

VL - 153

SP - 149

EP - 155

JO - American Journal of Clinical Pathology

JF - American Journal of Clinical Pathology

IS - 2

ER -

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

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