Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborator:
Baylor Research Institute
Information provided by (Responsible Party):
Michael Demeure, MD, Hoag Memorial Hospital Presbyterian

Tracking Information
First Submitted Date March 19, 2019
First Posted Date March 22, 2019
Last Update Posted Date March 22, 2019
Actual Study Start Date September 15, 2018
Estimated Primary Completion Date September 15, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title U01-Biomarkers for Noninvasive and Early Detection of Pancreatic Cancer
Official Title U01-Biomarkers for Noninvasive and Early Detection of Pancreatic Cancer
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Retention:   Samples With DNA
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.
Sampling Method Non-Probability Sample
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.
Condition Pancreatic Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 20, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 15, 2024
Estimated Primary Completion Date September 15, 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Deborah Fridman, PsyD, RN 949-764-5543 Clinicalresearch@hoag.org
Contact: Leila Andres, MS 949-764-5543 Clinicalresearch@hoag.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03886571
Other Study ID Numbers 119-17-CA
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Michael Demeure, MD, Hoag Memorial Hospital Presbyterian
Study Sponsor Hoag Memorial Hospital Presbyterian
Collaborators Baylor Research Institute
Investigators Not Provided
PRS Account Hoag Memorial Hospital Presbyterian
Verification Date March 2019