NCT03260842

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
48mo left

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Sep 2017Apr 2030

First Submitted

Initial submission to the registry

August 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

10.7 years

First QC Date

August 22, 2017

Last Update Submit

March 26, 2025

Conditions

Pancreatic CystPancreas Disease

Keywords

early detectionbiomarkerspancreas cancer

Outcome Measures

Primary Outcomes (1)

  • Pancreas Cancer

    Development of Pancreas Cancer

    5-10 years

Study Arms (2)

Pancreatic Cysts

Patients with pancreatic cyst undergoing endoscopic ultrasound and/or surgery who will have bio-specimens collected

Diagnostic Test: Bio-Specimen Collection

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

Interventions

Bio-Specimen CollectionDIAGNOSTIC_TEST

Collection of bio-specimens and observation over time.

High Risk IndividualsPancreatic Cysts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94035, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Pancreatic Cyst Fluid

MeSH Terms

Conditions

Pancreatic CystPancreatic DiseasesPancreatic Neoplasms

Condition Hierarchy (Ancestors)

CystsNeoplasmsDigestive System DiseasesDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsEndocrine System Diseases

Study Officials

  • Walter Park, MD

    Faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Walter Park, MD

CONTACT

650-723-4102wgpark@stanford.edu

Sharon Pneh

CONTACT

650-724-1336spneh@stanford.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2017

First Posted

August 24, 2017

Study Start

September 1, 2017

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2030

Last Updated

April 1, 2025

Record last verified: 2025-03

Locations

US(1)