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Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer

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ClinicalTrials.gov Identifier: NCT03260842
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Walter G. Park, M.D., M.S., Stanford University

Brief Summary:
Bio-repository to collect bio-specimens from patients with 1) pancreatic cysts and 2) patients at high risk, defined by family history and/or genetic mutations, for pancreatic cancer.

Condition or disease Intervention/treatment
Pancreatic Cyst Pancreas Disease Diagnostic Test: Bio-Specimen Collection

Detailed Description:

Observational study to collect bio-specimens from 2 separate patient cohorts identified to be at high risk for subsequent development of pancreas cancer.

  1. Patients diagnosed with a pancreatic cyst undergoing either endoscopic ultrasound or surgery. Bio-specimens collected include pancreatic cyst fluid and blood. These will be collected using a standard operating protocol within the NIH Pancreatic Cancer Detection Consortium.
  2. Patients defined as a high risk individual for pancreas cancer by family history and/or known genetic mutations. Bio-specimens collected include blood. This will be collected using a standard operating protocol within the NIH Pancreatic Cancer Detection Consortium.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bio-Repository of High Risk Cohorts for the Early Detection of Pancreas Cancer
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pancreatic Cysts
Patients with pancreatic cyst undergoing endoscopic ultrasound and/or surgery who will have bio-specimens collected
Diagnostic Test: Bio-Specimen Collection
Collection of bio-specimens and observation over time.

High Risk Individuals
Patients with established family history and/or genetic mutations for Pancreas cancer who will have bio-specimens collected
Diagnostic Test: Bio-Specimen Collection
Collection of bio-specimens and observation over time.




Primary Outcome Measures :
  1. Pancreas Cancer [ Time Frame: 5-10 years ]
    Development of Pancreas Cancer


Biospecimen Retention:   Samples With DNA
Blood and Pancreatic Cyst Fluid


Information from the National Library of Medicine

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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
Patients at high risk for developing pancreas cancer defined by the presence of a pancreatic cyst and/or family history or genetic mutation for pancreas cancer.
Criteria

Inclusion Criteria:

  • Older than 18 with pancreas cyst
  • Older than 18 at high risk for Pancreas cancer

Exclusion Criteria:

  • Unable to provide consent
  • Not willing to provide bio-specimens

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): NCT03260842


Contacts
Contact: Walter Park, MD 650-723-4102 wgpark@stanford.edu
Contact: Christina Vu 650-724-1336 ctvu@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94035
Contact: Walter Park, MD       wgpark@stanford.edu   
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Walter Park, MD Faculty

Responsible Party: Walter G. Park, M.D., M.S., Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03260842     History of Changes
Other Study ID Numbers: IRB-19286
U01CA210020 ( U.S. NIH Grant/Contract )
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified clinical and demographic variables may be shared and linked to bio-specimens.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Walter G. Park, M.D., M.S., Stanford University:
early detection
biomarkers
pancreas cancer

Additional relevant MeSH terms:
Pancreatic Diseases
Pancreatic Neoplasms
Pancreatic Cyst
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Cysts
Pancrelipase
Pancreatin
Gastrointestinal Agents