Pancreatic CystUCSF PCRNCT04291651
UCSF PANC Cyst Registry
An observational study of Pancreatic Cyst and Pancreatic Neoplasms, run by University of California, San Francisco at 1 site in United States.
Trial summary
Pancreatic cysts are found incidentally on 15-50% of CT and MRIs for all indications and their prevalence is increasing. Many of these cysts may be precursors to pancreatic cancer, and thus pose a substantial risk, however, the vast majority are benign. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Cancer
- What is being tested?
- Survey
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2019to 1 Jan 2030
- How long will I take part?
- 10 Years
- 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: The majority of patients in this study will be over the age of 60 years old, due to the natural age distribution of pancreatic cysts. There will be an approximately even distribution of males and females.
Who may be able to join
- The inclusion criteria for this study are intentionally broad. Eligible patients for prospective enrollment will include
- Adults ≥ 30 years of age
- Have a radiographic or endoscopic diagnosis of at least one pancreatic cysts regardless of treatment status,
- No history of pancreatic cancer,
- Can speak and read English,
- Have access to a computer or mobile device (~95% of U.S. population); and
- Are able to complete an electronic informed consent.
Who cannot join
- Patients who don't speak English,
- Don't have access to a computer or mobile device; or
- Patients who have a cancer diagnosis.
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
University of California, San Francisco
San Francisco, California, 94143
Charysa Santos, BS, 415-514-6914, Charysa.Santos@ucsf.edu
M.D., 877-827-3222, cancertrials@ucsf.edu
About this study
Official title: Population-Based Analysis of Neoplastic Changes in Cystic Lesions of the Pancreas.
Pancreatic cysts are found incidentally on 15-50% of CT and MRIs for all indications and their prevalence is increasing. Many of these cysts may be precursors to pancreatic cancer, and thus pose a substantial risk, however, the vast majority are benign. Increased detection of pancreatic cysts provides an opportunity to diagnose pancreatic malignancy at an early, curable stage yet also increases the potential to over-treat clinically insignificant lesions. This presents a clinical challenge to prevent unnecessary resection of indolent disease, with associated risks of infections, bleeding, diabetes, and costly disability. Unfortunately, there is little information on the epidemiology and natural history of pancreatic cysts to help guide management.
Read the detailed description
This study develops a large, prospectively managed, electronic, patient-directed pancreatic cyst registry based at UCSF. The UCSF Pancreatic Cystic Lesions Registry (PANC Cyst) will facilitate work to improve clinical care and understanding of pancreatic cysts by prospective follow-up of patients with cystic lesions, especially the diagnostically challenging small cysts, to identify factors related to cyst formation and progression to malignancy. Longitudinal data capture that includes clinical outcomes will also enable us to more precisely define anatomic, radiographic and biomarker information that can be used to differentiate populations of patients for whom surgery is indicated, surveillance is warranted, or no further evaluation is necessary.
- Conditions
- Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Cancer, Pancreatic Diseases, Pancreatic Intraductal Papillary Mucinous Neoplasm, Intraductal Papillary Mucinous Neoplasm
- Being tested
- Survey
- Keywords
- Pancreatic Cyst, Pancreatic Cystic Lesion, Pancreatic Cancer, Intraductal Papillary Mucinous Neoplasm, Serous Cystadenoma, Mucinous Cystic Neoplasm, Cancer Epidemiology, Early Detection Research
- Medical subject headings
- Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Diseases, Pancreatic Intraductal Neoplasms, Mucocele, Cystadenoma, Serous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
There are no study-specific interventions, as this is a prospective registry. However, patients will be asked to complete approximately 1-2 hours worth of surveys on things such as demographics, medical and surgical history, and pancreatic cyst-specific questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | The registry will be populated with a retrospective cohort of patients previously identified as having pancreatic cysts. | |
| Prospective | The prospectively enrolled patients in this study are the primary population of interest. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer
While not the primary outcome measure, the development of cancer from a pancreatic cyst is a critically important study endpoint, which the investigators do not expect to be frequent occurrence.
Measured: 1-10 years
Indolency
If a patient with a pancreatic cyst experiences no or minimal change in size, and no development of worrisome or high-risk stigmata (Tanaka 2017), this will be considered to be an indolent lesion. Most patients will fall under this category.
Measured: 1-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start8 Oct 2019
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 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 University of California, San FranciscoThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimberly S Kirkwood, MD, Principal investigator, University of California, San FranciscoPaige M Bracci, PhD, MPH, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291651
- Sponsor's protocol ID
- 214521
- Acronym
- UCSF PCR
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2020
- Last updated
- 22 Sep 2026
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-Based Analysis of Neoplastic Changes in Cystic Lesions of the Pancreas.
- ClinicalTrials.gov ID
- NCT04291651
- Acronym / sponsor ID
- UCSF PCR / 214521
- Conditions
- Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Cancer, Pancreatic Diseases, Pancreatic Intraductal Papillary Mucinous Neoplasm, Intraductal Papillary Mucinous Neoplasm
- Keywords
- Pancreatic Cyst, Pancreatic Cystic Lesion, Pancreatic Cancer, Intraductal Papillary Mucinous Neoplasm, Serous Cystadenoma, Mucinous Cystic Neoplasm, Cancer Epidemiology, Early Detection Research
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 2 Mar 2020 (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.
Pancreatic cysts are found incidentally on 15-50% of CT and MRIs for all indications and their prevalence is increasing. Many of these cysts may be precursors to pancreatic cancer, and thus pose a substantial risk, however, the vast majority are benign. Increased detection of pancreatic cysts provides an opportunity to diagnose pancreatic malignancy at an early, curable stage yet also increases the potential to over-treat clinically insignificant lesions. This presents a clinical challenge to prevent unnecessary resection of indolent disease, with associated risks of infections, bleeding, diabetes, and costly disability. Unfortunately, there is little information on the epidemiology and natural history of pancreatic cysts to help guide management.
Detailed description
This study develops a large, prospectively managed, electronic, patient-directed pancreatic cyst registry based at UCSF. The UCSF Pancreatic Cystic Lesions Registry (PANC Cyst) will facilitate work to improve clinical care and understanding of pancreatic cysts by prospective follow-up of patients with cystic lesions, especially the diagnostically challenging small cysts, to identify factors related to cyst formation and progression to malignancy. Longitudinal data capture that includes clinical outcomes will also enable us to more precisely define anatomic, radiographic and biomarker information that can be used to differentiate populations of patients for whom surgery is indicated, surveillance is warranted, or no further evaluation is necessary.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | –The registry will be populated with a retrospective cohort of patients previously identified as having pancreatic cysts. |
| Prospective | – | Other: SurveyThe prospectively enrolled patients in this study are the primary population of interest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The majority of patients in this study will be over the age of 60 years old, due to the natural age distribution of pancreatic cysts. There will be an approximately even distribution of males and females.
Key inclusion criteria (7 listed)
- The inclusion criteria for this study are intentionally broad. Eligible patients for prospective enrollment will include
- Adults ≥ 30 years of age
- Have a radiographic or endoscopic diagnosis of at least one pancreatic cysts regardless of treatment status,
- No history of pancreatic cancer,
- Can speak and read English,
Key exclusion criteria (3 listed)
- Patients who don't speak English,
- Don't have access to a computer or mobile device; or
- Patients who have a cancer diagnosis.
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 |
|---|---|---|
| SurveyThere are no study-specific interventions, as this is a prospective registry. However, patients will be asked to complete approximately 1-2 hours worth of surveys on things such as demographics, medical and surgical history, and pancreatic cyst-specific questionnaires. | Other | Prospective |
Primary outcome
Cancer
Time frame: 1-10 years
While not the primary outcome measure, the development of cancer from a pancreatic cyst is a critically important study endpoint, which the investigators do not expect to be frequent occurrence.
Indolency
Time frame: 1-10 years
If a patient with a pancreatic cyst experiences no or minimal change in size, and no development of worrisome or high-risk stigmata (Tanaka 2017), this will be considered to be an indolent lesion. Most patients will fall under this category.
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 22 Sep 2026.
- 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.
Kimberly S Kirkwood, MD principal investigator
University of California, San Francisco
Paige M Bracci, PhD, MPH, MS principal investigator
University of California, San Francisco
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 Pancreatic Neoplasms, run by University of California, San Francisco 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 7 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. 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 Charysa Santos, BS (415-514-6914, Charysa.Santos@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer (time frame: 1-10 years). 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 22 Sep 2026.