A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer

A prospective comparison study of serum maicroRNA panel versus CA19-9 for the diagnosis of pancreatobiliary cancer - Serum miRNA panel in the diagnosis of pancreatobiliary cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022063

Enrollment

1280

Registered

2016-07-01

Start date

2020-02-28

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

Pancreatobiliary cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: healty subjects, patients with inflammatory pancreatobiliary disease, or patients with pancreatobiliary cancer or gastrointestinal cancer

Exclusion criteria

Exclusion criteria: patients with inflammatory pancreatobiliary disease and malignant disease, patients with anti-cancer treatment for cancer

Design outcomes

Primary

Measure	Time frame
1. In discriminating pancreatobiliary cancer from healthy control, non-inferiority of specificity of serum miRNA panel when comparing the reported CA19-9 data (90-95%) and superiority of sensitivity of serum miRNA panel when comparing CA19-9 2. In discriminating pancreatobiliary cancer from inflammatory pancreatobiliary disease, non-inferiority of sensitivity of serum miRNA panel when comparing the reported CA19-9 data (70-80%) and superiority of specificity of serum miRNA panel when comparing CA19-9	—

Measure

Time frame

1. In discriminating pancreatobiliary cancer from healthy control, non-inferiority of specificity of serum miRNA panel when comparing the reported CA19-9 data (90-95%) and superiority of sensitivity of serum miRNA panel when comparing CA19-9 2. In discriminating pancreatobiliary cancer from inflammatory pancreatobiliary disease, non-inferiority of sensitivity of serum miRNA panel when comparing the reported CA19-9 data (70-80%) and superiority of specificity of serum miRNA panel when comparing CA19-9

—

Countries

Japan

Contacts

Public ContactShuichi Mitsunaga

National Cancer Center Hospital East Deparment of Hepatobiliary and Pancreatic Oncology

smitsuna@east.ncc.go.jp+81-7133-1111

Outcome results