Bio-Repository of High Risk Cohorts for the Early Detecti... | NCT03260842

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

NCT03260842

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

Apr 1, 2025Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Pancreatic Cyst
Pancreas Disease

Interventions

Bio-Specimen Collection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Apr 30, 2028Estimated

Completion Date

Apr 30, 2030Estimated

First Submitted Date

Aug 22, 2017

First Submission Date that Met QC Criteria

Aug 22, 2017

First Posted Date

Aug 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2025

Last Update Posted Date

Apr 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Bio-Specimen Collection	Diagnostic Test	Collection of bio-specimens and observation over time.	High Risk Individuals Pancreatic Cysts

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pancreas Cancer	Development of Pancreas Cancer	5-10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Walter Park, MD	Contact	650-723-4102		wgpark@stanford.edu
Sharon Pneh	Contact	650-724-1336		spneh@stanford.edu

Overall Officials

Name	Affiliation	Role
Walter Park, MD	Faculty	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University	Recruiting	Stanford	California	94035	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

De-identified clinical and demographic variables may be shared and linked to bio-specimens.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010181	Pancreatic Cyst
D010182	Pancreatic Diseases
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D003560	Cysts
D009369	Neoplasms
D004066	Digestive System Diseases
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided