Population-Based Analysis of Neoplastic Changes in Cystic Lesions of the Pancreas.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 4,000
- Locations
- 1
- Primary Endpoint
- Cancer
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported