Variability in biopsy quality informs translational research applications in hepatocellular carcinoma
Abstract In the era of precision medicine, biopsies are playing an increasingly central role in cancer research and treatment paradigms; however, patient outcomes and analyses of biopsy quality, as well as impact on downstream clinical and research applications, remain underreported. Herein, we repo...
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2021
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oai:doaj.org-article:d0f2766d8b2b4876b049000c66dab2792021-11-28T12:19:55ZVariability in biopsy quality informs translational research applications in hepatocellular carcinoma10.1038/s41598-021-02093-62045-2322https://doaj.org/article/d0f2766d8b2b4876b049000c66dab2792021-11-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-02093-6https://doaj.org/toc/2045-2322Abstract In the era of precision medicine, biopsies are playing an increasingly central role in cancer research and treatment paradigms; however, patient outcomes and analyses of biopsy quality, as well as impact on downstream clinical and research applications, remain underreported. Herein, we report biopsy safety and quality outcomes for percutaneous core biopsies of hepatocellular carcinoma (HCC) performed as part of a prospective clinical trial. Patients with a clinical diagnosis of HCC were enrolled in a prospective cohort study for the genetic, proteomic, and metabolomic profiling of HCC at two academic medical centers from April 2016 to July 2020. Under image guidance, 18G core biopsies were obtained using coaxial technique at the time of locoregional therapy. The primary outcome was biopsy quality, defined as tumor fraction in the core biopsy. 56 HCC lesions from 50 patients underwent 60 biopsy events with a median of 8 core biopsies per procedure (interquartile range, IQR, 7–10). Malignancy was identified in 45/56 (80.4%, 4 without pathology) biopsy events, including HCC (40/56, 71.4%) and cholangiocarcinoma (CCA) or combined HCC-CCA (5/56, 8.9%). Biopsy quality was highly variable with a median of 40% tumor in each biopsy core (IQR 10–75). Only 43/56 (76.8%) and 23/56 (41.1%) samples met quality thresholds for genomic or metabolomic/proteomic profiling, respectively, requiring expansion of the clinical trial. Overall and major complication rates were 5/60 (8.3%) and 3/60 (5.0%), respectively. Despite uniform biopsy protocol, biopsy quality varied widely with up to 59% of samples to be inadequate for intended purpose. This finding has important consequences for clinical trial design and highlights the need for quality control prior to applications in which the presence of benign cell types may substantially alter findings.Kelley WeinfurtnerJoshua ChoDaniel AckermanJames X. ChenAbashai WoodardWuyan LiDavid OstrowskiMichael C. SoulenMandeep DagliSusan Shamimi-NooriJeffrey MondscheinDeepak SudheendraS. William StavropoulosShilpa ReddyJonas RedmondTamim KhaddashDarshana JhalaEvan S. SiegelmanEmma E. FurthStephen J. HuntGregory J. NadolskiDavid E. KaplanTerence P. F. GadeNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-10 (2021) |
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Medicine R Science Q Kelley Weinfurtner Joshua Cho Daniel Ackerman James X. Chen Abashai Woodard Wuyan Li David Ostrowski Michael C. Soulen Mandeep Dagli Susan Shamimi-Noori Jeffrey Mondschein Deepak Sudheendra S. William Stavropoulos Shilpa Reddy Jonas Redmond Tamim Khaddash Darshana Jhala Evan S. Siegelman Emma E. Furth Stephen J. Hunt Gregory J. Nadolski David E. Kaplan Terence P. F. Gade Variability in biopsy quality informs translational research applications in hepatocellular carcinoma |
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Abstract In the era of precision medicine, biopsies are playing an increasingly central role in cancer research and treatment paradigms; however, patient outcomes and analyses of biopsy quality, as well as impact on downstream clinical and research applications, remain underreported. Herein, we report biopsy safety and quality outcomes for percutaneous core biopsies of hepatocellular carcinoma (HCC) performed as part of a prospective clinical trial. Patients with a clinical diagnosis of HCC were enrolled in a prospective cohort study for the genetic, proteomic, and metabolomic profiling of HCC at two academic medical centers from April 2016 to July 2020. Under image guidance, 18G core biopsies were obtained using coaxial technique at the time of locoregional therapy. The primary outcome was biopsy quality, defined as tumor fraction in the core biopsy. 56 HCC lesions from 50 patients underwent 60 biopsy events with a median of 8 core biopsies per procedure (interquartile range, IQR, 7–10). Malignancy was identified in 45/56 (80.4%, 4 without pathology) biopsy events, including HCC (40/56, 71.4%) and cholangiocarcinoma (CCA) or combined HCC-CCA (5/56, 8.9%). Biopsy quality was highly variable with a median of 40% tumor in each biopsy core (IQR 10–75). Only 43/56 (76.8%) and 23/56 (41.1%) samples met quality thresholds for genomic or metabolomic/proteomic profiling, respectively, requiring expansion of the clinical trial. Overall and major complication rates were 5/60 (8.3%) and 3/60 (5.0%), respectively. Despite uniform biopsy protocol, biopsy quality varied widely with up to 59% of samples to be inadequate for intended purpose. This finding has important consequences for clinical trial design and highlights the need for quality control prior to applications in which the presence of benign cell types may substantially alter findings. |
format |
article |
author |
Kelley Weinfurtner Joshua Cho Daniel Ackerman James X. Chen Abashai Woodard Wuyan Li David Ostrowski Michael C. Soulen Mandeep Dagli Susan Shamimi-Noori Jeffrey Mondschein Deepak Sudheendra S. William Stavropoulos Shilpa Reddy Jonas Redmond Tamim Khaddash Darshana Jhala Evan S. Siegelman Emma E. Furth Stephen J. Hunt Gregory J. Nadolski David E. Kaplan Terence P. F. Gade |
author_facet |
Kelley Weinfurtner Joshua Cho Daniel Ackerman James X. Chen Abashai Woodard Wuyan Li David Ostrowski Michael C. Soulen Mandeep Dagli Susan Shamimi-Noori Jeffrey Mondschein Deepak Sudheendra S. William Stavropoulos Shilpa Reddy Jonas Redmond Tamim Khaddash Darshana Jhala Evan S. Siegelman Emma E. Furth Stephen J. Hunt Gregory J. Nadolski David E. Kaplan Terence P. F. Gade |
author_sort |
Kelley Weinfurtner |
title |
Variability in biopsy quality informs translational research applications in hepatocellular carcinoma |
title_short |
Variability in biopsy quality informs translational research applications in hepatocellular carcinoma |
title_full |
Variability in biopsy quality informs translational research applications in hepatocellular carcinoma |
title_fullStr |
Variability in biopsy quality informs translational research applications in hepatocellular carcinoma |
title_full_unstemmed |
Variability in biopsy quality informs translational research applications in hepatocellular carcinoma |
title_sort |
variability in biopsy quality informs translational research applications in hepatocellular carcinoma |
publisher |
Nature Portfolio |
publishDate |
2021 |
url |
https://doaj.org/article/d0f2766d8b2b4876b049000c66dab279 |
work_keys_str_mv |
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