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

• Sponsor: Stanford University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03260842
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 67.9
• Patients Per Site Per Month: 7.4

Study Details

Study Description

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	Phase
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 Design

• Study Type: Observational
• Anticipated 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: Sep 1, 2017
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Pancreas Cancer [5-10 years]

   Development of Pancreas Cancer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94035

Sponsors and Collaborators

• Stanford University
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Walter Park, MD, Faculty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Walter G. Park, M.D., M.S., Principal Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT03260842
• Other Study ID Numbers: IRB-19286; U01CA210020
• First Posted: Aug 24, 2017
• Last Update Posted: Apr 14, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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., Principal Investigator, Stanford University: early detection; biomarkers; pancreas cancer
• Additional relevant MeSH terms: Pancreatic Neoplasms; Pancreatic Cyst; Pancreatic Diseases

Study Results

No Results Posted as of Apr 14, 2022