Pancreatic CancerNCT03214991
Circulating Tumor DNA as a Prognostic Marker in Patients With Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Ji Kon Ryu at 1 site in South Korea.
Trial summary
The aim of this study is to determine the usefulness of circulating tumor DNA as a prognostic factor in patients with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 May 2017to 31 Mar 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with pancreatic cancer through EUS-FNA.
Who may be able to join
- Patients diagnosed with pancreatic cancer through EUS-FNA.
Who cannot join
- Severe mental illness
- Severe co-morbidity (ESRD, Advanced COPD, severe Heart failure, poorly controlled blood sugar)
- Pregnancy
- Patients who have received chemotherapy
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Young Hoon Choi, MD, 82-2-2072-2228, crzyzs@naver.com
About this study
The aim of this study is to determine the usefulness of circulating tumor DNA as a prognostic factor in patients with pancreatic cancer.
Read the detailed description
There is currently no strong prognostic factor in pancreatic cancer. K-ras is the most commonly mutated gene in pancreatic cancer, with a mutation rate of 75% to 95%. These high mutation rates are expected to be useful for diagnosis and prognostic factors in future. Currently, K-ras mutation tests are often performed in tissues, and there are various limitations, in particular, limited obtaining of sufficient tissues. In this regard, analyzing the prognosis of pancreatic cancer through non-invasive blood testing has significant advantages. And Prognosis analysis through blood tests can be done through blood circulating tumor DNA. The relationship between prognosis and blood circulating tumor DNA has already been studied in other cancers such as colorectal cancer, and there have been several studies in pancreatic cancer. However, there are not many research results yet, and there are cases in which the results differ from study to study. Therefore, the purpose of this study is to compare the overall survival of patients with pancreatic cancer diagnosed by EUS-FNA according to the presence and amount of blood circulating tumor DNA with K-ras mutation.
- Conditions
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Comparison of overall survival rates between patients with and without blood-circulating tumor DNA
Measured: 48 months
Secondary outcomes (5)
Overall survival rate according to the amount of blood circulating tumor DNA
Overall survival rate according to the amount of blood circulating tumor DNA
Measured: 48mo
K-ras mutation
The concordance rate of K-ras mutation in EUS-FNA specimen and K-ras mutation in blood circulating tumor DNA
Measured: 48 months
Overall survival rate (EUS-FNA)
Overall survival rate with or without K-ras mutation of EUS-FNA specimen
Measured: 48 months
Overall survival rate (K-ras mutation type, circulating tumor DNA)
Overall survival rate according to K-ras mutation type in blood circulating tumor DNA
Measured: 48 months
Overall survival rate (K-ras mutation type, EUS-FNA)
Overall survival rate according to K-ras mutation type in EUS-FNA specimen
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start12 May 2017
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Mar 2021 (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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ji Kon Ryu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Kon Ryu, Seoul National University Hospital
- Investigators
- Ji Kon Ryu, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214991
- Sponsor's protocol ID
- 1704-108-847
- Status last verified
- Feb 2018
- First submitted
- 11 Jul 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA as a Prognostic Marker in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03214991
- Acronym / sponsor ID
- 1704-108-847
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ji Kon RyuUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 12 Jul 2017 (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.
The aim of this study is to determine the usefulness of circulating tumor DNA as a prognostic factor in patients with pancreatic cancer.
Detailed description
There is currently no strong prognostic factor in pancreatic cancer. K-ras is the most commonly mutated gene in pancreatic cancer, with a mutation rate of 75% to 95%. These high mutation rates are expected to be useful for diagnosis and prognostic factors in future. Currently, K-ras mutation tests are often performed in tissues, and there are various limitations, in particular, limited obtaining of sufficient tissues. In this regard, analyzing the prognosis of pancreatic cancer through non-invasive blood testing has significant advantages. And Prognosis analysis through blood tests can be done through blood circulating tumor DNA. The relationship between prognosis and blood circulating tumor DNA has already been studied in other cancers such as colorectal cancer, and there have been several studies in pancreatic cancer. However, there are not many research results yet, and there are cases in which the results differ from study to study. Therefore, the purpose of this study is to compare the overall survival of patients with pancreatic cancer diagnosed by EUS-FNA according to the presence and amount of blood circulating tumor DNA with K-ras mutation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with pancreatic cancer through EUS-FNA.
Key inclusion criteria (1 listed)
- Patients diagnosed with pancreatic cancer through EUS-FNA.
Key exclusion criteria (5 listed)
- Severe mental illness
- Severe co-morbidity (ESRD, Advanced COPD, severe Heart failure, poorly controlled blood sugar)
- Pregnancy
- Patients who have received chemotherapy
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival rate
Time frame: 48 months
Comparison of overall survival rates between patients with and without blood-circulating tumor DNA
5 secondary outcomes
Overall survival rate according to the amount of blood circulating tumor DNA
Time frame: 48mo
K-ras mutation
Time frame: 48 months
Overall survival rate (EUS-FNA)
Time frame: 48 months
Overall survival rate (K-ras mutation type, circulating tumor DNA)
Time frame: 48 months
Overall survival rate (K-ras mutation type, EUS-FNA)
Time frame: 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Ji Kon Ryu, MD, PhD principal investigator
Seoul National University Hospital
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 Ji Kon Ryu 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 1 inclusion and 5 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 5 Feb 2018. 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 Young Hoon Choi, MD (82-2-2072-2228, crzyzs@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival rate (time frame: 48 months). 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 5 Feb 2018.