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A phase II study of the proportion of criteria for The OncoGuide NCC Oncopanel System for the specimen of unresectable pancreatic cancer obtained by TopGain for EUS-guided fine-needle biopsy

A phase II study of the proportion of criteria for The OncoGuide NCC Oncopanel System for the specimen of unresectable pancreatic cancer obtained by TopGain for EUS-guided fine-needle biopsy - A phase II study of the proportion of criteria for NCC Oncopanel for the specimen of unresectable pancreatic cancer obtained by EUS-FNB

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043038
Enrollment
33
Registered
2021-01-20
Start date
2021-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

EUS-FNB using TopGain

Sponsors

National Cancer Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Unresectable pancreatic cancer and Invasive pancreatic ductal cancer depicted by contrast-enhanced computed tomography 2)ECOG performance status =0, 1, 2 3)Has not received chemotherapy for pancreatic cancer 4)No intervening blood vessels or other tumors between the lumen of the digestive tract and the target lesion 5)No bleeding tendency 6)No history of resection or reconstructive surgery of the esophagus, stomach, or duodenum 7)No massive ascites involving the liver 8)The patient's written consent to participate in the study has been obtained

Exclusion criteria

Exclusion criteria: 1)The physician determines that the patient's enrollment in the study is inappropriate

Design outcomes

Primary

MeasureTime frame
The proportion of criteria for the NCC Oncopanel for the specimen obtained by EUS-guided fine-needle biopsy

Secondary

MeasureTime frame
1)Tumor cellularity and tissue area 2)The proportion of criteria for the FoundationOne 3)Tumor cellularity and tissue area by the nCounter system 4)The true proportion of criteria for the NCC Oncopanel and FoundationOne 5)Accuracy, sensitivity, specificity, technical success rate and complication rate (bleeding and pancreatitis) 6)A comparison of the proportion of criteria for the NCC Oncopanel between primary and metastatic lesion 7)Type of genetic mutation 8)The proportion of patients who actually received gene therapy 9)A comparison of OS and PFS between patients who actually received gene therapy and not received

Countries

Japan

Contacts

Public ContactKosuke Maehara

National Cancer Center Hospital Department of Hepatobiliary and Pancreatic Oncology

kmaehara@ncc.go.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026