Pancreatic CystNCT05497271
Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions
An observational study of Pancreatic Cyst and Molecular, Chemical Analysis of Cystic Fluid, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Through a comprehensive analysis of the pancreatic cystic fluid analysis, the role of the cystic fluid analysis is confirmed in terms of accurate diagnosis of pancreatic cysts, appropriate prediction of treatment response, and to select proper treatment indication through analytic results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cyst, Molecular, Chemical Analysis of Cystic Fluid
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2017to 31 Dec 2025
- How long will I take part?
- 10 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
- No healthy volunteers
- Adult, Older adult
Study population: patients who were diagnosed with pancreatic cystic lesions and managed in Seoul National University Hospital
Who may be able to join
- patients who diagnosed with pancreatic cystic lesion
- patients who are able to acquire cystic fluid through EUS-FNA or surgery
- patients aged 18 years and older
Who cannot join
- patients who did not want to participate in this study
- patients aged under 18 years old
- severely mentally ill patients
- pregnant women
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, 01087036267, gidoctor@snu.ac.kr
Sang Hyub Lee, MD PhD
About this study
Official title: Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions and Study of Its Application for Diagnosis, Treatment and Prognosis
Through a comprehensive analysis of the pancreatic cystic fluid analysis, the role of the cystic fluid analysis is confirmed in terms of accurate diagnosis of pancreatic cysts, appropriate prediction of treatment response, and to select proper treatment indication through analytic results.
- Medical subject headings
- Pancreatic Cyst
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy by cystic fluid analysis
diagnostic accuracy by cystic fluid analysis in comparison with pathologic diagnosis
Measured: up to 5 years after cystic fluid analysis
Secondary outcomes (9)
Overall survival
overall survival until death
Measured: up to 5 years after cystic fluid analysis or surgical resection
Disease free survival
Period till tumor recurrence after surgical resection or intervention
Measured: up to 5 years after cystic fluid analysis or surgical resection
Malignant transformation rate
the prevalence of malignant transformation during follow-up period (percent)
Measured: up to 5 years after cystic fluid analysis
Prediction for treatment response in case of surgical resected or EUS-guided ethanol ablated pancreatic cysts
evaluation of treatment response for surgery of EUS guided therapy according to RECIST criteria v1.1
Measured: up to 5 years after cystic fluid analysis or EUS guided ablative therapy
Cytology of cystic fluid
result of cytology of cystic fluid
Measured: within 2 months after study enrollment
Chemical profile of CEA in cystic fluid
level of CEA in cystic fluid
Measured: within 2 months after study enrollment
Chemical profile of Amylase in cystic fluid
level of amylase in cystic fluid
Measured: within 2 months after study enrollment
Chemical profile of glucose in cystic fluid
level of glucose in cystic fluid
Measured: within 2 months after study enrollment
DNA mutation profile of cystic fluid
targeted NGS for KRAS, NRAS, CDKN2A, TP53, SMAD4, RNF43, PTEN, PIK3CA, VHL, Aneuploid
Measured: within 2 months after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Jan 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CystStudies 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
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Hyub Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497271
- Sponsor's protocol ID
- H-2206-213-1336
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions and Study of Its Application for Diagnosis, Treatment and Prognosis
- ClinicalTrials.gov ID
- NCT05497271
- Acronym / sponsor ID
- H-2206-213-1336
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Aug 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.
Through a comprehensive analysis of the pancreatic cystic fluid analysis, the role of the cystic fluid analysis is confirmed in terms of accurate diagnosis of pancreatic cysts, appropriate prediction of treatment response, and to select proper treatment indication through analytic results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who were diagnosed with pancreatic cystic lesions and managed in Seoul National University Hospital
Key inclusion criteria (3 listed)
- patients who diagnosed with pancreatic cystic lesion
- patients who are able to acquire cystic fluid through EUS-FNA or surgery
- patients aged 18 years and older
Key exclusion criteria (4 listed)
- patients who did not want to participate in this study
- patients aged under 18 years old
- severely mentally ill patients
- pregnant women
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
diagnostic accuracy by cystic fluid analysis
Time frame: up to 5 years after cystic fluid analysis
diagnostic accuracy by cystic fluid analysis in comparison with pathologic diagnosis
9 secondary outcomes
Overall survival
Time frame: up to 5 years after cystic fluid analysis or surgical resection
Disease free survival
Time frame: up to 5 years after cystic fluid analysis or surgical resection
Malignant transformation rate
Time frame: up to 5 years after cystic fluid analysis
Prediction for treatment response in case of surgical resected or EUS-guided ethanol ablated pancreatic cysts
Time frame: up to 5 years after cystic fluid analysis or EUS guided ablative therapy
Cytology of cystic fluid
Time frame: within 2 months after study enrollment
Chemical profile of CEA in cystic fluid
Time frame: within 2 months after study enrollment
Chemical profile of Amylase in cystic fluid
Time frame: within 2 months after study enrollment
Chemical profile of glucose in cystic fluid
Time frame: within 2 months after study enrollment
DNA mutation profile of cystic fluid
Time frame: within 2 months after study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 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 Cyst and Molecular, Chemical Analysis of Cystic Fluid, 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 4 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 12 Aug 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy by cystic fluid analysis (time frame: up to 5 years after cystic fluid analysis). 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 12 Aug 2022.