Pancreatic CystNCT03260842
Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer
An observational study of Pancreatic Cyst and Pancreas Disease, run by Stanford University at 1 site in United States.
Trial summary
Bio-repository to collect bio-specimens from patients with 1) pancreatic cysts and 2) patients at high risk, defined by family history and/or genetic mutations, for pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cyst, Pancreas Disease
- What is being tested?
- Bio-Specimen Collection
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 30 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 at high risk for developing pancreas cancer defined by the presence of a pancreatic cyst and/or family history or genetic mutation for pancreas cancer.
Who may be able to join
- Older than 18 with pancreas cyst
- Older than 18 at high risk for Pancreas cancer
Who cannot join
- Unable to provide consent
- Not willing to provide bio-specimens
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94035
Walter Park, MD, wgpark@stanford.edu
About this study
Bio-repository to collect bio-specimens from patients with 1) pancreatic cysts and 2) patients at high risk, defined by family history and/or genetic mutations, for pancreatic cancer.
Read the detailed description
Observational study to collect bio-specimens from 2 separate patient cohorts identified to be at high risk for subsequent development of pancreas cancer.
- Patients diagnosed with a pancreatic cyst undergoing either endoscopic ultrasound or surgery. Bio-specimens collected include pancreatic cyst fluid and blood. These will be collected using a standard operating protocol.
- Patients defined as a high risk individual for pancreas cancer by family history and/or known genetic mutations. Bio-specimens collected include blood. This will be collected using a standard operating protocol.
- Conditions
- Pancreatic Cyst, Pancreas Disease
- Being tested
- Bio-Specimen Collection
- Keywords
- early detection, biomarkers, pancreas cancer
- Medical subject headings
- Pancreatic Cyst, Pancreatic Diseases, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-Specimen CollectionDiagnostic test
Collection of bio-specimens and observation over time.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Cysts | Patients with pancreatic cyst undergoing endoscopic ultrasound and/or surgery who will have bio-specimens collected Receives: Diagnostic Test: Bio-Specimen Collection | |
| High Risk Individuals | Patients with established family history and/or genetic mutations for Pancreas cancer who will have bio-specimens collected Receives: Diagnostic Test: Bio-Specimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreas Cancer
Development of Pancreas Cancer
Measured: 5-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start1 Sep 2017
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2030 (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 Stanford UniversityThe 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)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter G. Park, M.D., M.S., Stanford University
- Investigators
- Walter Park, MD, Principal investigator, Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260842
- Sponsor's protocol ID
- IRB-19286
- Status last verified
- Mar 2025
- First submitted
- 22 Aug 2017
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified clinical and demographic variables may be shared and linked to bio-specimens.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer
- ClinicalTrials.gov ID
- NCT03260842
- Acronym / sponsor ID
- IRB-19286
- Conditions
- Pancreatic Cyst, Pancreas Disease
- Keywords
- early detection, biomarkers, pancreas cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 24 Aug 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.
Bio-repository to collect bio-specimens from patients with 1) pancreatic cysts and 2) patients at high risk, defined by family history and/or genetic mutations, for pancreatic cancer.
Detailed description
Observational study to collect bio-specimens from 2 separate patient cohorts identified to be at high risk for subsequent development of pancreas cancer.
- Patients diagnosed with a pancreatic cyst undergoing either endoscopic ultrasound or surgery. Bio-specimens collected include pancreatic cyst fluid and blood. These will be collected using a standard operating protocol.
- Patients defined as a high risk individual for pancreas cancer by family history and/or known genetic mutations. Bio-specimens collected include blood. This will be collected using a standard operating protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Cysts | – | Diagnostic Test: Bio-Specimen CollectionPatients with pancreatic cyst undergoing endoscopic ultrasound and/or surgery who will have bio-specimens collected |
| High Risk Individuals | – | Diagnostic Test: Bio-Specimen CollectionPatients with established family history and/or genetic mutations for Pancreas cancer who will have bio-specimens collected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at high risk for developing pancreas cancer defined by the presence of a pancreatic cyst and/or family history or genetic mutation for pancreas cancer.
Key inclusion criteria (2 listed)
- Older than 18 with pancreas cyst
- Older than 18 at high risk for Pancreas cancer
Key exclusion criteria (2 listed)
- Unable to provide consent
- Not willing to provide bio-specimens
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 |
|---|---|---|
| Bio-Specimen CollectionCollection of bio-specimens and observation over time. | Diagnostic test | High Risk Individuals, Pancreatic Cysts |
Primary outcome
Pancreas Cancer
Time frame: 5-10 years
Development of Pancreas Cancer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: Undecided. De-identified clinical and demographic variables may be shared and linked to bio-specimens.
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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.
Walter Park, MD principal investigator
Faculty
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 Pancreas Disease, run by Stanford University at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 1 Apr 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Walter Park, MD (650-723-4102, wgpark@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreas Cancer (time frame: 5-10 years). 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 1 Apr 2025.