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
|Condition or disease||Intervention/treatment|
|Pancreatic Cyst Pancreatic Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic IPMN IPMN Pancreatic Ductal Adenocarcinoma Mucinous Cyst||Other: Survey|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||4000 participants|
|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|
The registry will be populated with a retrospective cohort of patients previously identified as having pancreatic cysts.
The prospectively enrolled patients in this study are the primary population of interest.
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.
- 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.
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.
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
|Contact: Gina Zhu, BS||415-502-8739||Gina.firstname.lastname@example.org|
|Contact: Kimberly S Kirkwood, MDemail@example.com|
|United States, California|
|UCSF Medical Center||Recruiting|
|San Francisco, California, United States, 94158|
|Contact: Gina Zhu, BS 415-502-8739 Gina.firstname.lastname@example.org|
|Principal Investigator:||Kimberly S Kirkwood, MD||University of California, San Francisco|
|Principal Investigator:||Paige M Bracci, PhD, MPH, MS||University of California, San Francisco|