U01-Biomarkers for Noninvasive and Early Detection of Pancreatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03886571|
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
|Condition or disease|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||U01-Biomarkers for Noninvasive and Early Detection of Pancreatic Cancer|
|Actual Study Start Date :||September 15, 2018|
|Estimated Primary Completion Date :||September 15, 2023|
|Estimated Study Completion Date :||September 15, 2024|
- 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. [ Time Frame: 5 years ]
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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886571
|Contact: Deborah Fridman, PsyD, RN||949-764-5543||Clinicalresearch@hoag.org|
|Contact: Leila Andres, MS||949-764-5543||Clinicalresearch@hoag.org|
|United States, California|
|Hoag Memorial Hospital Presbyterian||Recruiting|
|Newport Beach, California, United States, 92663|
|Contact: Deborah Fridman, PsyD, RN 949-764-5543 Clinicalresearch@hoag.org|
|Contact: Leila Andres, MS 949-764-5543 Clinicalresearch@hoag.org|
|Principal Investigator: Michael Demeure, MD|