DNA Mutation Detection in Circulating Tumor DNA and Tissue by mmADPS for Pancreatic Cancer
1 other identifier
observational
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2022
CompletedFirst Submitted
Initial submission to the registry
October 24, 2022
CompletedFirst Posted
Study publicly available on registry
November 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedNovember 3, 2022
November 1, 2022
2.9 years
October 24, 2022
November 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
correlation of genetic mutation
concordance of genetic mutation between tissue and blood of treatment-naive status
the day of study enrollment (baseline)
detection sensitivity of genetic mutation by mmADPS
detection sensitivity of genetic mutation by mmADPS
the day of study enrollment (baseline)
Secondary Outcomes (1)
correlation of genetic mutation and prognosis
through study completion, an average of 1 year
Study Arms (2)
pancreatic cancer
patients with pancreatic cancer
control
patients without any malignancy
Interventions
Diagnostic test for cell free DNA in blood, genetic mutation in tissue
Eligibility Criteria
Patients aged 18 or older who diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- GENECAST Co., Ltd.collaborator
Study Sites (1)
Seoul National University Hospital
Seoul, 101, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 24, 2022
First Posted
November 3, 2022
Study Start
February 9, 2022
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
November 3, 2022
Record last verified: 2022-11