Proportion of unresectable pancreatic cancer specimens obtained by endoscopic ultrasound-guided tissue acquisition meeting the OncoGuide™ NCC Oncopanel System analysis suitability criteria: a single-arm, phase II clinical trial

Hisada, Yuya; Hijioka, Susumu; Ikeda, Go; Maehara, Kosuke; Hashimoto, Taiki; Kitamura, Hidetoshi; Harai, Shota; Yoshinari, Motohiro; Kawasaki, Yuki; Murashima, Yumi; Koga, Takehiko; Takeshita, Kotaro; Maruki, Yuta; Ohba, Akihiro; Nagashio, Yoshikuni; Kondo, Shunsuke; Morizane, Chigusa; Ueno, Hideki; Saito, Yutaka; Yatabe, Yasushi; Okusaka, Takuji

doi:10.1007/s00535-022-01926-z

Cited by 24 publications

(27 citation statements)

References 20 publications

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“…Several studies have demonstrated NOP analysis suitability criteria for EUS-FNB using a 19-guage needle for patients with unresectable PC [ 22 , 35 ]. Moreover, one prospective and two retrospective studies have reported on comprehensive genomic testing using 22-guage FNB needles [ 36 , 37 , 38 ].…”

Section: Discussionmentioning

confidence: 99%

“…A recent study reported that EUS-FNB is a useful sampling technique for genomic profiling, DNA, and histology yield in patients with PC [ 20 , 21 ]. Hisada et al showed that endoscopic ultrasound–guided tissue acquisition using a 19-G FNB needle is effective in achieving the proportion meeting the NOP analysis suitability criteria in patients with unresectable PC [ 22 ].…”

Section: Introductionmentioning

confidence: 99%

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Next-Generation Sequencing Analysis of Pancreatic Cancer Using Residual Liquid Cytology Specimens from Endoscopic Ultrasound—Guided Fine-Needle Biopsy: A Prospective Comparative Study with Tissue Specimens

et al. 2023

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This study evaluated the feasibility and clinical utility of liquid-based cytology (LBC) specimens via endoscopic ultrasound–guided fine-needle biopsy (EUS-FNB) for next-generation sequencing (NGS) of pancreatic cancer (PC). We prospectively evaluated the performance of DNA extraction and NGS using EUS-FNB samples obtained from PC. Thirty-three consecutive patients with PC who underwent EUS-FNB at our hospital were enrolled. DNA samples were obtained from 96.8% of the patients. When stratified with a variant allele frequency (VAF) > 10% tumor burden, the NGS success rate was 76.7% (n = 23) in formalin-fixed paraffin-embedded (FFPE), 83.3% (n = 25) in LBC, and 76.7% (n = 23) in frozen samples. The overall NGS success rate was 86.7% (n = 26) using FFPE, LBC, or frozen samples. The detection rates for the main mutated genes were as follows: 86.7% for KRAS, 73.3% for TP53, 66.7% for CDKN2A, 36.7% for SMAD4, and 16.7% for ARID1A. LBC had the highest median value of VAF (23.5%) for KRAS and TP53. PC mutation analysis using NGS was successfully performed using LBC compared with FFPE and frozen samples. This approach provides an alternative and affordable source of molecular testing materials.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Next-Generation Sequencing Analysis of Pancreatic Cancer Using Residual Liquid Cytology Specimens from Endoscopic Ultrasound—Guided Fine-Needle Biopsy: A Prospective Comparative Study with Tissue Specimens

et al. 2023

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“…However, an area of ≥4 mm 2 has been usually reported to be sufficient to obtain the recommended amount of total DNA, 6–8 which is less than that of F1CDx. According to previous reports, 0%, 23.8%, and 0% of the specimens collected using EUS‐TA met the criteria for F1CDx, respectively, while 63.6%, 56.0%, and 39.2% met the criteria for NOP 1,4,5 . Therefore, in this novel study, we focused on whether the surface area of the tissue sections obtained by EUS‐TA was >4 mm 2 .…”

Section: Introductionmentioning

confidence: 90%

“…One of the requirements for F1CDx is that the surface area of the tissue sections collected must be at least 25 mm 2 . However, the success rate of specimens collected by ultrasound endoscopy‐guided tissue acquisition (EUS‐TA) and submitted to F1CDx for analysis is poor, ranging between 0% and 70.4% 1–5 . The NOP recommends a surface area of approximately 16 mm 2 for tissue sections collected for reliable testing.…”

Section: Introductionmentioning

confidence: 99%

Comparison of the novel Franseen needle versus the fine‐needle aspiration needle in endoscopic ultrasound‐guided tissue acquisition for cancer gene panel testing: A propensity score‐matching analysis

Mori,

Ozawa,

Shimakura

et al. 2023

JGH Open

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Background and AimReports have indicated that a surface area of 4 mm2 or more of collected tissue sections could provide the recommended total DNA for the OncoGuide NCC Oncopanel system, which is a cancer gene panel test developed in Japan. We wished to compare the percentage of tissue sections collected by endoscopic ultrasound‐assisted tissue acquisition (EUS‐TA) with surface areas of ≥4 mm2 between a conventional needle, namely the EZ Shot 3 Plus (Olympus Medical Japan, Tokyo, Japan) (EZ3), and the recent SonoTip TopGain (MediGlobe, Rohrdorf, Germany) (TopGain).MethodFrom April 2010 to December 2021, among 693 EUS‐TA cases, EZ3 was used in 390 cases and TopGain in 45. The EZ3 and TopGain groups were matched in a 1:1 ratio with a tolerance of 0.2, with 35 patients each matched using propensity score analysis.ResultsThe TopGain group had a significantly higher percentage of cases with a tissue area of ≥4 mm2 than the EZ3 group (42.9% vs 68.6%, P = 0.030). Multivariate analysis revealed an association between TopGain and tissue areas of ≥4 mm2 (odds ratio 2.996, 95% confidence interval 1.068–8.403, P = 0.037).ConclusionsEUS‐TA using TopGain significantly collected more ≥4 mm2 tissue area compared with EZ3, suggesting its usefulness for cancer gene panel testing.

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“…A prospective study [ 49 ] with a primary endpoint of the percentage of specimens obtained by EUS-TA using a 19-G FNB needle achieving NCCOP analysis criteria reported that the proportion of patients meeting the predefined criteria to be considered valid was 63.6% (95% CI: 47.22–80.05). The median tumor cell content was 60% (range: 7.5–85).…”

Section: Tips For Improving the Success Rate Of Cgp Analysis With Eus...mentioning

confidence: 99%

Endoscopic Ultrasound-Guided Tissue Acquisition of Pancreaticobiliary Cancer Aiming for a Comprehensive Genome Profile

Hijioka¹,

Nagashio²,

Maruki³

et al. 2023

Diagnostics

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In recent years, cancer genomic medicine centered on comprehensive genome profile (CGP) analysis has become widely used in the field of pancreatic cancer. Endoscopic ultrasound-guided tissue acquisition (EUS-TA) has played an important role in pancreatic cancer, and recently, more EUS-TA tissue samples are considered for CGP analysis. Differences exist between the Oncoguide NCC Oncopanel System and Foundation One CDx Cancer Genome Profile, which are CGP tests approved by insurance programs in Japan, including the analysis criteria, optimal needle selection for meeting these criteria, and puncture target. It is important to understand not only the specimen collection factors, but also the specimen processing factors that can increase the success rate of CGP testing. Furthermore, cancer genome medicine is expected to enter an era of increasing turbulence in the future, and endoscopists need to respond flexibly to these changes. Herein, we review the current status of cancer genome medicine in pancreatic and biliary tract cancers and cancer gene panel testing using EUS-TA.

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Proportion of unresectable pancreatic cancer specimens obtained by endoscopic ultrasound-guided tissue acquisition meeting the OncoGuide™ NCC Oncopanel System analysis suitability criteria: a single-arm, phase II clinical trial

Cited by 24 publications

References 20 publications

Next-Generation Sequencing Analysis of Pancreatic Cancer Using Residual Liquid Cytology Specimens from Endoscopic Ultrasound—Guided Fine-Needle Biopsy: A Prospective Comparative Study with Tissue Specimens

Next-Generation Sequencing Analysis of Pancreatic Cancer Using Residual Liquid Cytology Specimens from Endoscopic Ultrasound—Guided Fine-Needle Biopsy: A Prospective Comparative Study with Tissue Specimens

Comparison of the novel Franseen needle versus the fine‐needle aspiration needle in endoscopic ultrasound‐guided tissue acquisition for cancer gene panel testing: A propensity score‐matching analysis

Endoscopic Ultrasound-Guided Tissue Acquisition of Pancreaticobiliary Cancer Aiming for a Comprehensive Genome Profile

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