DNA Mutation Detection in Circulating Tumor DNA and Tissue by mmADPS for Pancreatic Cancer

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Diagnostic Test: cell free DNA in blood, genetic mutation in tissue

• Registration Number: NCT05604573
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Based on the cell free nucleic acid analysis information of blood samples and genetic mutation profile of EUS-FNB tissue from pancreatic cancer, the concordance between them is evaluated. And based on this information, biomarkers for diagnosis, treatment, and prognosis of pancreatic cancer are explored.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-09
• Study First Submitted: 2022-10-24
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-02
• Last Update Submitted: 2022-11-02
• Study First Posted: 2022-11-03
• Last Update Posted: 2022-11-03
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins
• Patients aged 18 or older who voluntarily agrees to participate in the study and is willing to understand and comply with the subsequent treatment procedures and sample collection schedule
• Among patients diagnosed with benign pancreatic diseases (pancreatic cyst, chronic pancreatitis, etc.), patients who have need for histological examination as control group

Exclusion Criteria

• Where the subject himself/herself refuses to fill out the consent form or is unable to fill out the consent form
• If a laboratory test is impossible due to a qualitative problem with the collected blood sample
• Where the collected tissue does not contain tissue of the desired malignant or benign disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pancreatic cancer	cell free DNA in blood, genetic mutation in tissue	patients with pancreatic cancer
control	cell free DNA in blood, genetic mutation in tissue	patients without any malignancy

Primary Outcome Measures

Name	Time	Method
detection sensitivity of genetic mutation by mmADPS	the day of study enrollment (baseline)	detection sensitivity of genetic mutation by mmADPS
correlation of genetic mutation	the day of study enrollment (baseline)	concordance of genetic mutation between tissue and blood of treatment-naive status

Secondary Outcome Measures

Name	Time	Method
correlation of genetic mutation and prognosis	through study completion, an average of 1 year	correlation of genetic mutation and prognosis

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of