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

Phase 2

• Conditions: Pancreatobiliary cancer

• Registration Number: JPRN-UMIN000022063
• Lead Sponsor: Japan Agency for Medical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-01
• Study Completion: 2020-12-19
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 1487

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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