Pancreatic CancerNCT05604573
DNA Mutation Detection in Circulating Tumor DNA and Tissue by mmADPS for Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- cell free DNA in blood, genetic mutation in tissue
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Feb 2022to 31 Dec 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18 or older who diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 101
Sang Hyub Lee, MD PhD, +82-2-2072-2228, gidoctor@snu.ac.kr
Sang Hyub Lee, MD PhD
About this study
Official title: DNA Mutation Detection in Circulating Tumor DNA and Tissue by Massive Multiplex Allele Discrimination Priming System(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.
- Conditions
- Pancreatic Cancer
- Being tested
- cell free DNA in blood, genetic mutation in tissue
- Keywords
- Pancreatic cancer, Circulating Tumor DNA, DNA mutation, DNA methylation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell free DNA in blood, genetic mutation in tissueDiagnostic test
Diagnostic test for cell free DNA in blood, genetic mutation in tissue
| Study group | Role | What they receive |
|---|---|---|
| pancreatic cancer | patients with pancreatic cancer Receives: Diagnostic Test: cell free DNA in blood, genetic mutation in tissue | |
| control | patients without any malignancy Receives: Diagnostic Test: cell free DNA in blood, genetic mutation in tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of genetic mutation
concordance of genetic mutation between tissue and blood of treatment-naive status
Measured: the day of study enrollment (baseline)
detection sensitivity of genetic mutation by mmADPS
detection sensitivity of genetic mutation by mmADPS
Measured: the day of study enrollment (baseline)
Secondary outcomes (1)
correlation of genetic mutation and prognosis
correlation of genetic mutation and prognosis
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start9 Feb 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GENECAST Co., Ltd.
- Responsible party
- Principal investigator, Sang Hyub Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604573
- Sponsor's protocol ID
- H-2111-047-1271
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Mutation Detection in Circulating Tumor DNA and Tissue by Massive Multiplex Allele Discrimination Priming System(mmADPS) for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05604573
- Acronym / sponsor ID
- H-2111-047-1271
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, Circulating Tumor DNA, DNA mutation, DNA methylation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- GENECAST Co., Ltd.
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pancreatic cancer | – | Diagnostic Test: cell free DNA in blood, genetic mutation in tissuepatients with pancreatic cancer |
| control | – | Diagnostic Test: cell free DNA in blood, genetic mutation in tissuepatients without any malignancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 or older who diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cell free DNA in blood, genetic mutation in tissueDiagnostic test for cell free DNA in blood, genetic mutation in tissue | Diagnostic test | control, pancreatic cancer |
Primary outcome
correlation of genetic mutation
Time frame: the day of study enrollment (baseline)
concordance of genetic mutation between tissue and blood of treatment-naive status
detection sensitivity of genetic mutation by mmADPS
Time frame: the day of study enrollment (baseline)
detection sensitivity of genetic mutation by mmADPS
1 secondary outcome
correlation of genetic mutation and prognosis
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Hyub Lee, Ph.D (+82-2-2072-2228, gidoctor@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of genetic mutation (time frame: the day of study enrollment (baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.