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


Journal

American journal of clinical pathology
ISSN: 1943-7722
Titre abrégé: Am J Clin Pathol
Pays: England
ID NLM: 0370470

Informations de publication

Date de publication:
02 01 2020
Historique:
pubmed: 16 10 2019
medline: 23 4 2020
entrez: 16 10 2019
Statut: ppublish

Résumé

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. 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. The expert views and opinions were carefully noted and reported. Recommendations were proposed to reduce institutional barriers and to assist organizations in developing clear policies regarding diagnostic block submission for clinical trials.

Identifiants

pubmed: 31613330
pii: 5587750
doi: 10.1093/ajcp/aqz141
pmc: PMC7169836
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

149-155

Subventions

Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA233339
Pays : United States

Commentaires et corrections

Type : CommentIn

Informations de copyright

© American Society for Clinical Pathology, 2019.

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Auteurs

Hala Makhlouf (H)

Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD.

Mark A Watson (MA)

Department of Pathology and Immunology, Washington University School of Medicine, St Louis, MO.

Heather A Lankes (HA)

Biopathology Center, The Research Institute at Nationwide Children's Hospital, Columbus, OH.

Carol Weil (C)

Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD.

Maura Dickler (M)

Breast Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.

Michael Birrer (M)

Division of Hematology-Oncology, Comprehensive Cancer Center, University of Alabama at Birmingham, Charlottesville.

Christopher Moskaluk (C)

Department of Pathology, University of Virginia School of Medicine, Charlottesville.

Nilsa C Ramirez (NC)

Biopathology Center, The Research Institute at Nationwide Children's Hospital, Columbus, OH.

Nader Okby (N)

Department of Pathology, Orange Regional Medical Center, Middletown, NY.

Edgar Alonsozana (E)

Department of Pathology, Mercy Medical Center, Baltimore, MD.

Mark Barnes (M)

Ropes & Gray LLP and Multi-Regional Clinical Trials Center, Harvard University/Brigham and Women's Hospital, Boston, MA.

Edward B Goldman (EB)

Schools of Law and Medicine, University of Michigan, Ann Arbor.

Rebecca Enos (R)

The Emmes Corporation, Rockville, MD.

Irina Lubensky (I)

Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, MD.

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Classifications MeSH