Pancreatic CancerNCT02934984
Circulating Cell-free Tumor DNA(ctDNA) in Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA(ctDNA) can help early screening of pancreatic cancer recurrence or not. And we are also planning to evaluate correlation between ctDNA with clinical outcome of pancreatic cancer. Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2016to Jan 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive pancreatic cancer patients who received EUS-FNA for diangosis and undergo operation, benign pancreas disease patients who received EUS-FNA for diagnosis, healthy population
Who may be able to join
- Comparative group : Pancreatic cancer patients who progress endoscopic ultrasonography fine-needle aspiration (EUS-FNA) for pancreatic cancer diagnosis, pancreatic cancer patients who are in operable stage
- Control group : Benign pancreas disease patients who progress EUS-FNA for diagnosis, healthy population
Who cannot join
- Foreigners
- Pancreatic cancer patients who have other cancer
- Patients who impossible to consent to study by own
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Joo Kyung Park, MD, 82-2-3410-3409, mdsophie@gmail.com
About this study
Official title: Analysis of Factors Related to Pancreatic Cancer Recurrence Using Circulating Cell-free Tumor DNA(ctDNA)
The aim of the study is to evaluate whether peripheral circulating cell-free tumor DNA(ctDNA) can help early screening of pancreatic cancer recurrence or not. And we are also planning to evaluate correlation between ctDNA with clinical outcome of pancreatic cancer.
Read the detailed description
In the formation and growth of a primary tumor, cells can released into the bloodstream. There are many researches for these circulating tumor cells(CTC) And recently circulating cell-free tumor DNA(ctDNA) released from apoptotic or necrotic tumor cells has developed. At one report which checked ctDNA level after operation of colon cancer patients, they suggested that ctDNA could show recurrence of cancer several months earlier than the conventional follow up imaging. And several reports suggested that ctDNA can invade host cell and change host cell biology, which can evoke cancer metastasis.
So in this study, the investigator will collect ctDNA of pancreatic cancer patients, benign pancreatic disease patients, and healthy population. And the investigator will evaluate whether peripheral ctDNA can help early screening of cancer recurrence. And we will study about genomic signature of ctDNA to evaluate relationship between ctDNA and clinical outcome of cancer patients.
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, recurrence, DNA
- Medical subject headings
- Pancreatic Neoplasms, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of recurrence in pancreatic cancer patients
Measured: 36 months
Secondary outcomes (1)
Rates of death in pancreatic cancer patients
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2020 (estimated)
- Study completionJan 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.
- More trials run by Samsung Medical CenterThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JooKyung Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934984
- Sponsor's protocol ID
- 2016-07-054
- Status last verified
- Apr 2019
- First submitted
- 13 Oct 2016
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Factors Related to Pancreatic Cancer Recurrence Using Circulating Cell-free Tumor DNA(ctDNA)
- ClinicalTrials.gov ID
- NCT02934984
- Acronym / sponsor ID
- 2016-07-054
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer, recurrence, DNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 17 Oct 2016 (estimated)
- 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 the study is to evaluate whether peripheral circulating cell-free tumor DNA(ctDNA) can help early screening of pancreatic cancer recurrence or not. And we are also planning to evaluate correlation between ctDNA with clinical outcome of pancreatic cancer.
Detailed description
In the formation and growth of a primary tumor, cells can released into the bloodstream. There are many researches for these circulating tumor cells(CTC) And recently circulating cell-free tumor DNA(ctDNA) released from apoptotic or necrotic tumor cells has developed. At one report which checked ctDNA level after operation of colon cancer patients, they suggested that ctDNA could show recurrence of cancer several months earlier than the conventional follow up imaging. And several reports suggested that ctDNA can invade host cell and change host cell biology, which can evoke cancer metastasis.
So in this study, the investigator will collect ctDNA of pancreatic cancer patients, benign pancreatic disease patients, and healthy population. And the investigator will evaluate whether peripheral ctDNA can help early screening of cancer recurrence. And we will study about genomic signature of ctDNA to evaluate relationship between ctDNA and clinical outcome of cancer patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive pancreatic cancer patients who received EUS-FNA for diangosis and undergo operation, benign pancreas disease patients who received EUS-FNA for diagnosis, healthy population
Key inclusion criteria (2 listed)
- Comparative group : Pancreatic cancer patients who progress endoscopic ultrasonography fine-needle aspiration (EUS-FNA) for pancreatic cancer diagnosis, pancreatic cancer patients who are in operable stage
- Control group : Benign pancreas disease patients who progress EUS-FNA for diagnosis, healthy population
Key exclusion criteria (3 listed)
- Foreigners
- Pancreatic cancer patients who have other cancer
- Patients who impossible to consent to study by own
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
Rates of recurrence in pancreatic cancer patients
Time frame: 36 months
1 secondary outcome
Rates of death in pancreatic cancer patients
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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 Samsung Medical Center 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 2 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 17 Apr 2019. 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 Joo Kyung Park, MD (82-2-3410-3409, mdsophie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of recurrence in pancreatic cancer patients (time frame: 36 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 17 Apr 2019.