Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment
Pancreatic Cyst Pancreatic Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic IPMN IPMN Pancreatic Ductal Adenocarcinoma Mucinous Cyst Other: Survey

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Population-Based Analysis of Neoplastic Changes in Cystic Lesions of the Pancreas.
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : January 1, 2030
Estimated Study Completion Date : January 1, 2030

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.


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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04291651


Contacts
Layout table for location contacts
Contact: Gina Zhu, BS 415-502-8739 Gina.zhu@ucsf.edu
Contact: Kimberly S Kirkwood, MD 415-502-2131 kim.kirkwood@ucsf.edu

Locations
Layout table for location information
United States, California
UCSF Medical Center Recruiting
San Francisco, California, United States, 94158
Contact: Gina Zhu, BS    415-502-8739    Gina.zhu@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Eureka
Investigators
Layout table for investigator information
Principal Investigator: Kimberly S Kirkwood, MD University of California, San Francisco
Principal Investigator: Paige M Bracci, PhD, MPH, MS University of California, San Francisco
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04291651    
Other Study ID Numbers: 17-23574
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Pancreatic Cyst
Pancreatic Cystic Lesion
Pancreatic Cancer
Intraductal Papillary Mucinous Neoplasm
Serous Cystadenoma
Mucinous Cystic Neoplasm
Cancer Epidemiology
Early Detection Research
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms
Pancreatic Neoplasms
Cysts
Pancreatic Cyst
Pancreatic Intraductal Neoplasms
Pancreatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Pathological Conditions, Anatomical
Neoplasms, Ductal, Lobular, and Medullary