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

The value added of tumour blocks collected for research questions

A recently published article in the American Journal of Clinical Pathology about the submission of tumour blocks for NCTN trials is the result of work done by the Group Banking Committee of the US NCI which CCTG is a charter member.(Publication)

The article is a balanced discussion of the ongoing issues around the submission of representative tumour tissue on clinical studies, and reinforces the incredible value added of tumour blocks collected for research questions in the context of the trial. The findings, discussion, and conclusions were the result of a workshop held at the NCI and involved a survey of pathologists across the US. In Canada, a similar survey was conducted with almost identical results.

Many CCTG trials request the submission of tumour blocks for mandated or integrated biomarkers, or for future research questions. These requests are very carefully vetted by the Study Chairs and committees of our trials and have considerable input by a correlative science lead. All the material received is carefully stored under the stewardship of the Tumour, Tissue, Data Repository of the CCTG which is an accredited biorepository of the Canadian Tissue Repository Network.

The strength of a clinical trial associated biobank is in the very rich and carefully curated clinical data. Numerous high impact findings have resulted from the foresight involved in the collection of this material. In spite of the value of prospectively collecting this material, an increasing number of Canadian centres, for a variety of reasons, will not release a requested tumour blocks for which a patient has given consent to do so.

This work reinforces the very careful stewardship for material taken on by the biobanks, and enhance the understanding of the wishes of patients to support ongoing research that will provide insight into the successful treatment of their disease.

Toward Improving Practices for Submission of Diagnostic Tissue Blocks for National Cancer Institute Clinical Trials
Hala Makhlouf, MD, PhD,1 Mark A. Watson, MD, PhD,2 Heather A. Lankes, PhD, MPH,3 Carol Weil, JD,1 Maura Dickler, MD,4 Michael Birrer, MD, PhD,5 Christopher Moskaluk, MD, PhD,6 Nilsa C. Ramirez, MD,3 Nader Okby, MD,7 Edgar Alonsozana, MD,8 Mark Barnes, JD, LLM,9 Edward B. Goldman, JD,10 Rebecca Enos, ADN, MPH,11 and Irina Lubensky, MD1

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.

Publication