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NCT03260842 Clinical Trial

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

Pancreatic Cyst Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03260842
Other study ID # IRB-19286
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date April 30, 2030

Study information
Verified date April 2024
Source Stanford University
Contact Walter Park, MD
Phone 650-723-4102
Email wgpark@stanford.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date April 30, 2030
Est. primary completion date April 30, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Bio-Specimen Collection
Collection of bio-specimens and observation over time.

Locations
Country Name City State
United States Stanford University Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pancreas Cancer Development of Pancreas Cancer 5-10 years
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