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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. Identifier: NCT03886571
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Baylor Research Institute
Information provided by (Responsible Party):
Michael Demeure, MD, Hoag Memorial Hospital Presbyterian

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

Condition or disease
Pancreatic Cancer

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  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. [ 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
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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03886571

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Contact: Deborah Fridman, PsyD, RN 949-764-5543
Contact: Leila Andres, MS 949-764-5543

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United States, California
Hoag Memorial Hospital Presbyterian Recruiting
Newport Beach, California, United States, 92663
Contact: Deborah Fridman, PsyD, RN    949-764-5543   
Contact: Leila Andres, MS    949-764-5543   
Principal Investigator: Michael Demeure, MD         
Sponsors and Collaborators
Hoag Memorial Hospital Presbyterian
Baylor Research Institute
Additional Information:

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Responsible Party: Michael Demeure, MD, Program Director for Precision Medicine, Hoag Memorial Hospital Presbyterian Identifier: NCT03886571    
Other Study ID Numbers: 119-17-CA
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases