UCSF PANC Cyst Registry

NCT04291651 | Recruiting

• 1 other identifier: 214521
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pancreatic Cyst; Pancreatic Neoplasms; Pancreatic Cancer; Pancreatic Diseases; Pancreatic Intraductal Papillary Mucinous Neoplasm; Intraductal Papillary Mucinous Neoplasm; Pancreatic Ductal Adenocarcinoma; Mucinous Cyst

Keywords

Pancreatic Cyst; Pancreatic Cystic Lesion; Pancreatic Cancer; Intraductal Papillary Mucinous Neoplasm; Serous Cystadenoma; Mucinous Cystic Neoplasm; Cancer Epidemiology; Early Detection Research

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1-10 years

Study Arms (2)

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.

Other: Survey

Interventions

Survey OTHER

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.

Prospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients who don't speak English,
• Don't have access to a computer or mobile device; or
• Patients who have a cancer diagnosis.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Patients in this study will have the option of donating blood for biobanking, approximately 10cc of plasma and 10cc of serum. Patients will also have the opportunity to donate a saliva sample at the time of study registration, or at a later date. Further, samples that are routinely collected for diagnostic purposes may be collected and banked at the time of their clinically routine procedure. If a patient consents to the use of extra material for research purposes, the biological samples will be banked and the blood, and/or pancreatic juice/cystic fluid, tissues, and saliva will be used for identification and characterization of potential biomarkers from de-identified samples.

MeSH Terms

Conditions

Pancreatic Cyst; Pancreatic Neoplasms; Pancreatic Diseases; Pancreatic Intraductal Neoplasms; Mucocele; Cystadenoma, Serous

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Endocrine System Diseases; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Cystadenoma; Adenoma; Neoplasms, Cystic, Mucinous, and Serous

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kimberly S Kirkwood, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Paige M Bracci, PhD, MPH, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charysa Santos, BS

CONTACT

415-514-6914; Charysa.Santos@ucsf.edu

Kimberly S Kirkwood, MD

CONTACT

415-502-5577; kim.kirkwood@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 2, 2020
• Study Start: October 8, 2019
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)