Research Related Tumour Biopsies in Early-Phase Trials with Simultaneous Molecular Characterisation - a Single Unit Experience.
Adult
Aged
Clinical Trials as Topic
/ ethics
Drug Development
/ ethics
Drug Monitoring
/ adverse effects
Female
High-Throughput Nucleotide Sequencing
Humans
Image-Guided Biopsy
/ adverse effects
Immunohistochemistry
Informed Consent
Male
Middle Aged
Neoplasms
/ diagnosis
Retrospective Studies
Ultrasonography, Interventional
Drug development
Informed consent
Phase 1 cancer trials
Research biopsy
Research ethics
Sequencing
Journal
Cancer treatment and research communications
ISSN: 2468-2942
Titre abrégé: Cancer Treat Res Commun
Pays: England
ID NLM: 101694651
Informations de publication
Date de publication:
2021
2021
Historique:
received:
03
12
2020
revised:
07
01
2021
accepted:
08
01
2021
pubmed:
8
2
2021
medline:
1
1
2022
entrez:
7
2
2021
Statut:
ppublish
Résumé
Early-phase cancer clinical trials are becoming increasingly accessible for patients with advanced cancer who have exhausted standard treatment options and later phase trial options. Many of these trials mandate research tissue biopsies. Research biopsies have been perceived as ethically fraught due to the perception of potential coercion of vulnerable human subjects. We performed an audit of two years of practice to assess the safety of ultrasound (US)-guided research biopsies, and to look at the yield of a simultaneous tumour next-generation sequencing (NGS) and immunohistochemistry (IHC) molecular characterisation programme. We show that in our institution, US-guided research biopsies were safe, produced adequate tumour content and in a selected subset who underwent in-house NGS sequencing, showed a high rate of actionable mutations with 30% having a Tier 1 variant. Nevertheless, these research biopsies may only provide direct benefit for a minority of patients and we conclude with a reflection on the importance of obtaining truly informed consent.
Identifiants
pubmed: 33549985
pii: S2468-2942(21)00008-3
doi: 10.1016/j.ctarc.2021.100309
pii:
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
100309Subventions
Organisme : Cancer Research UK
Pays : United Kingdom
Informations de copyright
Copyright © 2021. Published by Elsevier Ltd.