DNA Mutation Detection In Circulating Tumor DNA And Tissue By MmADPS For Pancreatic Cancer

Study Overview

DNA Mutation Detection in Circulating Tumor DNA and Tissue by 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.

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Pancreatic Cancer

DIAGNOSTIC_TEST: cell free DNA in blood, genetic mutation in tissue

H-2111-047-1271

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-10-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-11-02
First Submitted that Met QC Criteria 2022-11-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-11-03
First Posted (ACTUAL) 2022-11-03	Results First Posted N/A	Last Verified 2022-11

Study Plan

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

Design Details

Primary Purpose:
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Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	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

Participant Group/Arm

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

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

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

Name: Sang Hyub Lee, Ph.D

Phone Number: +82-2-2072-2228

Email: [email protected]

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

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

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

Collaborators and Investigators

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

GENECAST Co., Ltd.

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record