Status unknownNCT05604573Updated Nov 3, 2022

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

An observational study in Pancreatic Cancer, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-03.

Sponsored by Seoul National University Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 150
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Pancreatic Cancer

Browse trials for

Pancreatic Neoplasms 3,235

Keywords

Pancreatic cancer
Circulating Tumor DNA
DNA mutation
DNA methylation

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 150 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
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

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

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 design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 150 participants (estimated)
Target follow-up: 3 Years
Patient registry: Yes

Groups and cohorts

pancreatic cancer
patients with pancreatic cancer
Diagnostic Test: 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

Interventions

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

What researchers measure

Primary outcomes

correlation of genetic mutation
concordance of genetic mutation between tissue and blood of treatment-naive status
Time frame: the day of study enrollment (baseline)
detection sensitivity of genetic mutation by mmADPS
detection sensitivity of genetic mutation by mmADPS
Time frame: the day of study enrollment (baseline)

Secondary outcomes

correlation of genetic mutation and prognosis
correlation of genetic mutation and prognosis
Time frame: through study completion, an average of 1 year

Study locations

1 of 1 sites recruiting

Seoul National University Hospital
Seoul, 101, Korea, Republic of
- Sang Hyub Lee, MD PhD · Contact · gidoctor@snu.ac.kr · +82-2-2072-2228
- Sang Hyub Lee, MD PhD · Principal investigator
- Jin Ho Choi, MD · Sub investigator
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05604573
Lead sponsor: Seoul National University Hospital
Collaborators: GENECAST Co., Ltd.
Responsible party: Sang Hyub Lee (Professor, Seoul National University Hospital) — Principal investigator
First posted: Nov 3, 2022
Start date: Feb 9, 2022
Primary completion: Dec 31, 2024 (estimated)
Completion: Dec 31, 2024 (estimated)
Last update: Nov 3, 2022

Study contacts

Sang Hyub Lee, Ph.D

Contact

gidoctor@snu.ac.kr

+82-2-2072-2228

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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