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

NCT ID: NCT05604573

Condition: Pancreatic Cancer

Conditions: Official terms:
Pancreatic Neoplasms

Conditions: Keywords:
Pancreatic cancer
Circulating Tumor DNA
DNA mutation
DNA methylation

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: cell free DNA in blood, genetic mutation in tissue
Description: Diagnostic test for cell free DNA in blood, genetic mutation in tissue
Arm group label: control
Arm group label: pancreatic cancer

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.

Criteria for eligibility:

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

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 101
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Sang Hyub Lee, MD PhD

Phone: +82-2-2072-2228
Email: gidoctor@snu.ac.kr

Investigator:
Last name: Sang Hyub Lee, MD PhD
Email: Principal Investigator

Investigator:
Last name: Jin Ho Choi, MD
Email: Sub-Investigator

Start date: February 9, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Seoul National University Hospital
Agency class: Other

Collaborator:
Agency: GENECAST Co., Ltd.
Agency class: Other

Source: Seoul National University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05604573

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