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

NCT ID: NCT05604573

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-09

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Pancreatic Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pancreatic cancer

patients with pancreatic cancer

cell free DNA in blood, genetic mutation in tissue

Intervention Type DIAGNOSTIC_TEST

Diagnostic test for cell free DNA in blood, genetic mutation in tissue

control

patients without any malignancy

cell free DNA in blood, genetic mutation in tissue

Intervention Type DIAGNOSTIC_TEST

Diagnostic test for cell free DNA in blood, genetic mutation in tissue

Interventions

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cell free DNA in blood, genetic mutation in tissue

Diagnostic test for cell free DNA in blood, genetic mutation in tissue

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GENECAST Co., Ltd.

UNKNOWN

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sang Hyub Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sang Hyub Lee, Ph.D

Role: CONTACT

+82-2-2072-2228

Facility Contacts

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Sang Hyub Lee, MD PhD

Role: primary

+82-2-2072-2228

Other Identifiers

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H-2111-047-1271

Identifier Type: -

Identifier Source: org_study_id

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