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

November 2, 2022 updated by: Sang Hyub Lee, Seoul National University Hospital

DNA Mutation Detection in Circulating Tumor DNA and Tissue by Massive Multiplex Allele Discrimination Priming System(mmADPS) for Pancreatic Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 101
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Sang Hyub Lee, MD PhD
        • Sub-Investigator:
          • Jin Ho Choi, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 or older who diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pancreatic cancer
patients with pancreatic cancer
Diagnostic test: cell free DNA in blood, genetic mutation in tissue
Diagnostic test for cell free DNA in blood, genetic mutation in tissue
control
patients without any malignancy
Diagnostic test: cell free DNA in blood, genetic mutation in tissue
Diagnostic test for cell free DNA in blood, genetic mutation in tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of genetic mutation
Time Frame: the day of study enrollment (baseline)
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
Time Frame: the day of study enrollment (baseline)
detection sensitivity of genetic mutation by mmADPS
the day of study enrollment (baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of genetic mutation and prognosis
Time Frame: through study completion, an average of 1 year
correlation of genetic mutation and prognosis
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

GENECAST Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 24, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 3, 2022

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2111-047-1271

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on cell free DNA in blood, genetic mutation in tissue

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe