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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05604573
Enrollment
150
Registered
2022-11-03
Start date
2022-02-09
Completion date
2024-12-31
Last updated
2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer, Circulating Tumor DNA, DNA mutation, DNA methylation

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.

Interventions

DIAGNOSTIC_TESTcell free DNA in blood, genetic mutation in tissue

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

Sponsors

GENECAST Co., Ltd.
CollaboratorUNKNOWN
Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
correlation of genetic mutationthe day of study enrollment (baseline)concordance of genetic mutation between tissue and blood of treatment-naive status
detection sensitivity of genetic mutation by mmADPSthe day of study enrollment (baseline)detection sensitivity of genetic mutation by mmADPS

Secondary

MeasureTime frameDescription
correlation of genetic mutation and prognosisthrough study completion, an average of 1 yearcorrelation of genetic mutation and prognosis

Countries

South Korea

Contacts

Primary ContactSang Hyub Lee, Ph.D
gidoctor@snu.ac.kr+82-2-2072-2228

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026