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

Recruiting

• Conditions: Pancreas Disease; Pancreatic Cyst
• Interventions: Diagnostic Test: Bio-Specimen Collection

• Registration Number: NCT03260842
• Lead Sponsor: 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.

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.

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.

Study Timeline

• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-22
• Study First Posted: 2017-08-24
• Study Start: 2017-09-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2028-04-30
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High Risk Individuals	Bio-Specimen Collection	Patients with established family history and/or genetic mutations for Pancreas cancer who will have bio-specimens collected
Pancreatic Cysts	Bio-Specimen Collection	Patients with pancreatic cyst undergoing endoscopic ultrasound and/or surgery who will have bio-specimens collected

Primary Outcome Measures

Name	Time	Method
Pancreas Cancer	5-10 years	Development of Pancreas Cancer

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States