Clinical trial NCT04291651: UCSF PANC Cyst Registry
Official title: Population-Based Analysis of Neoplastic Changes in Cystic Lesions of the Pancreas.
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cancer
timeFrame: 1-10 years
measure: Indolency
timeFrame: 1-10 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kimberly S Kirkwood, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Paige M Bracci, PhD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References: