UCSF PANC Cyst Registry (UCSF PCR)

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Neoplasms; Pancreatic Cancer; Pancreatic Diseases; Pancreatic Ductal Adenocarcinoma; Pancreatic Cyst; Intraductal Papillary Mucinous Neoplasm; Mucinous Cyst; Pancreatic Intraductal Papillary Mucinous Neoplasm
• Intervention / Treatment: Other: Survey

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 Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Charysa Santos, BS; Phone Number: 415-514-6914; Email: Charysa.Santos@ucsf.edu
• Study Contact Backup: Name: Kimberly S Kirkwood, MD; Phone Number: 415-502-5577; Email: kim.kirkwood@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Charysa Santos, BS; Phone Number: 415-514-6914; Email: Charysa.Santos@ucsf.edu
      • Contact: M.D.; Phone Number: 877-827-3222; Email: cancertrials@ucsf.edu
      • Principal Investigator: Kimberly Kirkwood, MD
      • Principal Investigator: Paige M Bracci, PhD, MPH, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Kimberly S Kirkwood, MD, University of California, San Francisco; Principal Investigator: Paige M Bracci, PhD, MPH, MS, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2019
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Intraductal Papillary Mucinous Neoplasm; Mucinous Cystic Neoplasm; Pancreatic Cyst; Cancer Epidemiology; Pancreatic Cystic Lesion; Serous Cystadenoma; Early Detection Research
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pathological Conditions, Anatomical; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms; Pancreatic Neoplasms; Pancreatic Diseases; Pancreatic Cyst; Neoplasms, Cystic, Mucinous, and Serous; Cysts; Pancreatic Intraductal Neoplasms
• Other Study ID Numbers: 214521

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No