U01-Biomarkers for Noninvasive and Early Detection of Pancreatic Cancer
1 other identifier
observational
100
1 country
1
Brief Summary
This is an observational, biospecimen collection protocol to develop a bank of pancreatic cancer tissue and normal tissue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
Longer than P75 for all trials
1 active site
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 Start
First participant enrolled
September 15, 2018
CompletedFirst Submitted
Initial submission to the registry
March 19, 2019
CompletedFirst Posted
Study publicly available on registry
March 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2024
CompletedMarch 1, 2023
February 1, 2023
5 years
March 19, 2019
February 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Individuals under 18 years of age.
- Inability to donate biospecimens.
- Females pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoag Memorial Hospital Presbyterianlead
- Baylor Research Institutecollaborator
Study Sites (1)
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Program Director for Precision Medicine
Study Record Dates
First Submitted
March 19, 2019
First Posted
March 22, 2019
Study Start
September 15, 2018
Primary Completion
September 15, 2023
Study Completion
September 15, 2024
Last Updated
March 1, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share