U01-Biomarkers for Noninvasive and Early Detection of Pan... | NCT03886571

Studies
U01-Biomarkers for Noninvasive and Early Detection of Pancreatic Cancer

NCT03886571

Sponsor

Hoag Memorial Hospital Presbyterian

Status

Unknown status

Last Update Posted

Mar 1, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Pancreatic Cancer

Interventions

Not provided

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2018Actual

Primary Completion Date

Sep 15, 2023Estimated

Completion Date

Sep 15, 2024Estimated

First Submitted Date

Mar 19, 2019

First Submission Date that Met QC Criteria

Mar 20, 2019

First Posted Date

Mar 22, 2019Actual

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

Feb 27, 2023

Last Update Posted Date

Mar 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Demeure, MD, Program Director for Precision Medicine, Hoag Memorial Hospital PresbyterianPrincipal Investigator

Lead Sponsor

Hoag Memorial Hospital PresbyterianOTHER

Collaborators

Name	Class
Baylor Research Institute	OTHER

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

This is an observational, biospecimen collection protocol to develop a bank of pancreatic cancer tissue and normal tissue.

Detailed Description

This is an observational, biospecimen collection protocol to develop a bank of pancreatic cancer tissue, normal tissue. Biospecimens collected through this protocol will be shared with collaborators in the Pancreatic Cancer Detection Consortium to support projects funded through an NIH U01 grant. Participants will be enrolled when they present for clinically indicated surgical procedures for their possible tumor or pancreas resection or cyst resection, or at a clinically indicated follow-up appointment after their procedure.

This protocol supports this effort by providing investigators with access to a wide variety of pancreatic tissues and biospecimens for translational studies in pancreatic cancer. This protocol covers the collection of clinical data and biospecimens (blood; malignant, benign, or precancerous pancreatic tumor; and adjacent normal tissues) from patients with, or suspected to have, pancreatic cancer. Additionally, saliva and cyst fluid, may be collected in the future from patients with pancreatic cysts. These will be shared with the Pancreatic Cancer Detection Consortium for further analysis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measuring cell-free and exosomal-miRNA biomarkers using small RNA-Seq in matched tissue and plasma from patients with PDAC, PNs, pancreatitis and normal pancreas for early detection.	We will perform whole genome small RNA sequencing (small RNA-Seq) analysis on tissue specimens from 60 primary PDACs (30 stage I/II and 30 Stage III/IV), 60 PNs (20 each PanINs, IPMNs and MCNs), and 60 non-neoplastic normal pancreatic tissues (NN) and pancreatitis. We will perform small RNA-Seq analysis to identify differentially expressed cell-free and exosomal miRNAs (cf-miRNAs and exo-miRNAs) from the same matched plasma specimens.	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or Females ≥ 18 years of age who have been diagnosed with Pancreatic Cancer (PDAC), Pancreatic Neoplasms (PNs - IPMMs, PanINs and MCNs), pancreatitis and diabetes or no disease/healthy.
Individuals undergoing or have previously undergone a diagnostic procedure (i.e. EUS or ERCP) evaluation or surgery.
Willingness and ability to donate biospecimens for the purpose of research.
Subjects must have had diagnostic procedure or surgery after September 1, 2017.

Exclusion Criteria:

Individuals under 18 years of age.
Inability to donate biospecimens.
Females pregnant or lactating.

Accepts Healthy Volunteers

Not provided

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 with an upcoming standard of care clinical and/or surgical event who meet criteria for study participation are identified by the treating physician and will be asked to participate in the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Leila Andres, MS	Contact	949-764-5543		Clinicalresearch@hoag.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hoag Memorial Hospital Presbyterian	Recruiting	Newport Beach	California	92663	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Up to 60 mL of blood will be obtained at study entry. Archived paraffin embedded blocks of both normal and tumor tissue and Up to 0.5 mL Pancreatic cyst fluid may be collected if the participant is undergoing an endoscopic or surgical procedure for a pancreatic cyst.