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UCSF Panc Cyst Registry (UCSF PCR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04291651
Recruitment Status : Recruiting
First Posted : March 2, 2020
Last Update Posted : September 1, 2021
Sponsor:
Collaborator:
Eureka
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date February 26, 2020
First Posted Date March 2, 2020
Last Update Posted Date September 1, 2021
Actual Study Start Date October 8, 2019
Estimated Primary Completion Date January 1, 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2020)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title UCSF Panc Cyst Registry
Official Title Population-Based Analysis of Neoplastic Changes in Cystic Lesions of the Pancreas.
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. This study develops a large, prospectively managed, electronic, patient-directed pancreatic cyst registry based at UCSF using the NIH-funded Eureka Health platform. 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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Retention:   Samples With DNA
Description:

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.

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.
Condition
  • Pancreatic Cyst
  • Pancreatic Neoplasms
  • Pancreatic Cancer
  • Pancreatic Diseases
  • Pancreatic IPMN
  • IPMN
  • Pancreatic Ductal Adenocarcinoma
  • Mucinous Cyst
Intervention 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.
Study Groups/Cohorts
  • 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.
    Intervention: Other: Survey
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 27, 2020)
4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2030
Estimated Primary Completion Date January 1, 2030   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Gina Zhu, BS 415-502-8739 Gina.zhu@ucsf.edu
Contact: Kimberly S Kirkwood, MD 415-502-2131 kim.kirkwood@ucsf.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04291651
Other Study ID Numbers 17-23574
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators Eureka
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
PRS Account University of California, San Francisco
Verification Date August 2021