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
© 2022. Japanese Society of Gastroenterology..
BACKGROUND: There are limited studies on the results of comprehensive genomic profiling testing for pancreatic cancer tissue specimens by endoscopic ultrasound-guided tissue acquisition (EUS-TA). This study aimed to evaluate the proportion of specimens obtained by EUS-TA using a 19-gauge (G) fine-needle biopsy (FNB) needle for unresectable pancreatic cancer (UR-PC) that met the OncoGuide™ NCC Oncopanel System (NOP) analysis suitability criteria.
METHODS: In this single-arm, prospective, phase II study, EUS-TA was performed using a 19G FNB biopsy needle in patients with suspected UR-PC based on a contrast-enhanced computed tomography scan. The primary endpoint was the proportion of patients who met the NOP analysis suitability criteria, with a threshold, expected value, α-error, and power of 40%, 70%, 0.025, and 0.9, respectively, and the planned number of enrolled patients was 33. The NOP analysis suitability criteria were defined as tumor cell content ≥ 20% and tissue size ≥ 4 mm2.
RESULTS: Thirty-three patients were enrolled. The procedural success rate was 100%, and the cytodiagnosis of class V was observed in all patients. The proportion of patients meeting the NOP analysis suitability criteria was 63.6% (95% CI 47.22-80.05), which satisfied the predefined criteria to be considered valid. Adverse events occurred in 9.0% of the patients.
CONCLUSIONS: The proportion of patients with UR-PC who met the NOP analysis suitability criteria for EUS-TA using a 19G FNB needle was effective for achieving the primary endpoint, making it a valid test method. Adverse events occurred at a higher rate than that previously reported.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:57 |
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| Enthalten in: |
Journal of gastroenterology - 57(2022), 12 vom: 01. Dez., Seite 990-998 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hisada, Yuya [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 16.11.2022 Date Revised 13.12.2023 published: Print-Electronic UMIN-CTR: UMIN-CTR 000043038 Citation Status MEDLINE |
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| doi: |
10.1007/s00535-022-01926-z |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM347061621 |
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| 100 | 1 | |a Hisada, Yuya |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Proportion of unresectable pancreatic cancer specimens obtained by endoscopic ultrasound-guided tissue acquisition meeting the OncoGuide™ NCC Oncopanel System analysis suitability criteria |b a single-arm, phase II clinical trial |
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| 500 | |a Date Revised 13.12.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a UMIN-CTR: UMIN-CTR 000043038 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022. Japanese Society of Gastroenterology. | ||
| 520 | |a BACKGROUND: There are limited studies on the results of comprehensive genomic profiling testing for pancreatic cancer tissue specimens by endoscopic ultrasound-guided tissue acquisition (EUS-TA). This study aimed to evaluate the proportion of specimens obtained by EUS-TA using a 19-gauge (G) fine-needle biopsy (FNB) needle for unresectable pancreatic cancer (UR-PC) that met the OncoGuide™ NCC Oncopanel System (NOP) analysis suitability criteria | ||
| 520 | |a METHODS: In this single-arm, prospective, phase II study, EUS-TA was performed using a 19G FNB biopsy needle in patients with suspected UR-PC based on a contrast-enhanced computed tomography scan. The primary endpoint was the proportion of patients who met the NOP analysis suitability criteria, with a threshold, expected value, α-error, and power of 40%, 70%, 0.025, and 0.9, respectively, and the planned number of enrolled patients was 33. The NOP analysis suitability criteria were defined as tumor cell content ≥ 20% and tissue size ≥ 4 mm2 | ||
| 520 | |a RESULTS: Thirty-three patients were enrolled. The procedural success rate was 100%, and the cytodiagnosis of class V was observed in all patients. The proportion of patients meeting the NOP analysis suitability criteria was 63.6% (95% CI 47.22-80.05), which satisfied the predefined criteria to be considered valid. Adverse events occurred in 9.0% of the patients | ||
| 520 | |a CONCLUSIONS: The proportion of patients with UR-PC who met the NOP analysis suitability criteria for EUS-TA using a 19G FNB needle was effective for achieving the primary endpoint, making it a valid test method. Adverse events occurred at a higher rate than that previously reported | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Comprehensive genomic profiling | |
| 650 | 4 | |a Endoscopic ultrasound-guided fine-needle biopsy | |
| 650 | 4 | |a Endoscopic ultrasound-guided tissue acquisition | |
| 650 | 4 | |a Next-generation sequencing | |
| 650 | 4 | |a Pancreatic cancer | |
| 700 | 1 | |a Hijioka, Susumu |e verfasserin |4 aut | |
| 700 | 1 | |a Ikeda, Go |e verfasserin |4 aut | |
| 700 | 1 | |a Maehara, Kosuke |e verfasserin |4 aut | |
| 700 | 1 | |a Hashimoto, Taiki |e verfasserin |4 aut | |
| 700 | 1 | |a Kitamura, Hidetoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Harai, Shota |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshinari, Motohiro |e verfasserin |4 aut | |
| 700 | 1 | |a Kawasaki, Yuki |e verfasserin |4 aut | |
| 700 | 1 | |a Murashima, Yumi |e verfasserin |4 aut | |
| 700 | 1 | |a Koga, Takehiko |e verfasserin |4 aut | |
| 700 | 1 | |a Takeshita, Kotaro |e verfasserin |4 aut | |
| 700 | 1 | |a Maruki, Yuta |e verfasserin |4 aut | |
| 700 | 1 | |a Ohba, Akihiro |e verfasserin |4 aut | |
| 700 | 1 | |a Nagashio, Yoshikuni |e verfasserin |4 aut | |
| 700 | 1 | |a Kondo, Shunsuke |e verfasserin |4 aut | |
| 700 | 1 | |a Morizane, Chigusa |e verfasserin |4 aut | |
| 700 | 1 | |a Ueno, Hideki |e verfasserin |4 aut | |
| 700 | 1 | |a Saito, Yutaka |e verfasserin |4 aut | |
| 700 | 1 | |a Yatabe, Yasushi |e verfasserin |4 aut | |
| 700 | 1 | |a Okusaka, Takuji |e verfasserin |4 aut | |
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