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Pancreatic Cancer Detection Consortium (PCDC)

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: NCT06388967
Recruitment Status : Recruiting
First Posted : April 29, 2024
Last Update Posted : April 29, 2024
Sponsor:
Information provided by (Responsible Party):
City of Hope Medical Center

Study Description
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Brief Summary:
This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma.

Condition or disease Intervention/treatment
Pancreatic Cancer Pancreatic Carcinoma Pancreatic Adenocarcinoma Pancreatic Ductal Adenocarcinoma Pancreatic Neoplasms Pancreatic Cancer Stage I Pancreatic Cancer Stage Pancreatic Cancer Resectable Pancreatic Cancer Stage 0 Pancreatic Cancer Stage II Pancreatic Cancer Stage III Pancreatic Cancer, Adult Pancreatic Cancer Non-resectable Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)

Detailed Description:

Pancreatic ductal adenocarcinoma (PDAC) is one of the deadliest forms of cancer. It often goes undetected until it is at an advanced stage, making it challenging to treat. Currently, only a small percentage of patients are diagnosed early enough for effective treatment. While a blood marker exists, called serum carbohydrate antigen 19-9 (CA19-9), it is used primarily to track the disease and it is unreliable for early detection.

To address this problem, the researchers have developed a new method to analyze circulating vesicles (called exosomes), which contain specific genetic material called microRNAs (miRNAs). In a previous study, by analyzing both the miRNAs that circulate freely in serum and the miRNAs that are inside the exosomes, the researchers have already identified a combination of 13 miRNAs that could accurately detect early-stage PDAC.

In this study, the researchers will test this method in a larger international cohort study. This study aims to confirm the effectiveness of this approach in accurately identifying PDAC at its earliest stages.

Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Early Detection of Pancreatic Cancer: Prospective Study
Actual Study Start Date : March 15, 2023
Estimated Primary Completion Date : November 21, 2025
Estimated Study Completion Date : November 21, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with Pancreatic Cancer Ductal Adenocarcinoma (Training)
Individuals diagnosed with pancreatic ductal adenocarcinoma
 Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)
This test will utilize quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) to quantify the expression levels of 5 cell-free and 8 exosome-miRNAs in plasma samples obtained from patients with pancreatic ductal adenocarcinoma and from individuals without it
Other Name: PANXEON (PANcreatic cancer Exosome Early detectiON)
Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Training)
Individuals without pancreatic ductal adenocarcinoma
 Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)
This test will utilize quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) to quantify the expression levels of 5 cell-free and 8 exosome-miRNAs in plasma samples obtained from patients with pancreatic ductal adenocarcinoma and from individuals without it
Other Name: PANXEON (PANcreatic cancer Exosome Early detectiON)
Patients with Pancreatic Cancer Ductal Adenocarcinoma (Validation)
Individuals diagnosed with pancreatic ductal adenocarcinoma
 Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)
This test will utilize quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) to quantify the expression levels of 5 cell-free and 8 exosome-miRNAs in plasma samples obtained from patients with pancreatic ductal adenocarcinoma and from individuals without it
Other Name: PANXEON (PANcreatic cancer Exosome Early detectiON)
Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Validation)
Individuals without pancreatic ductal adenocarcinoma
 Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)
This test will utilize quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) to quantify the expression levels of 5 cell-free and 8 exosome-miRNAs in plasma samples obtained from patients with pancreatic ductal adenocarcinoma and from individuals without it
Other Name: PANXEON (PANcreatic cancer Exosome Early detectiON)


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity [ Time Frame: Through study completion, an average of 1 year ]
    True positive rate: the probability of a positive test result, conditioned on the individual truly being positive


Secondary Outcome Measures :
  1. Specificity [ Time Frame: Through study completion, an average of 1 year ]
    True negative rate: the probability of a negative test result, conditioned on the individual truly being negative

  2. Accuracy [ Time Frame: Through study completion, an average of 1 year ]
    A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined


Biospecimen Retention:   Samples Without DNA
Serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Independent cohorts of individuals with and without pancreatic cancer (cases and controls, respectively)
Criteria

Inclusion Criteria:

  • Histological diagnosis of pancreatic ductal adenocarcinoma, stages I-IV (TNM classification, 8th edition)
  • Received standard diagnostic and staging procedures as per local guidelines, and at least one sample was drawn before receiving any curative-intent treatment.
  • Imaging- or endoscopy-based proof of lack of pancreatic ductal adenocarcinoma at the time of sampling (Non-disease controls)

Exclusion Criteria:

  • Lack of written informed consent.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT06388967


Contacts
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Contact: Ajay Goel, PhD 6262183452 AJGOEL@COH.ORG

Locations
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United States, Arizona
Translational Genomics Research Institute Recruiting
Phoenix, Arizona, United States, 85004
Contact: Daniel Von Hoff       dvh@tgen.org   
Principal Investigator: Daniel Von Hoff         
Sub-Investigator: Haiyong Han         
Sub-Investigator: Derek Cridebring         
Honorhealth Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Erkut Borazanci       erkut.borazanci@honorhealth.com   
Sub-Investigator: Erkut Borazanci         
United States, California
City of Hope Medical Center Recruiting
Monrovia, California, United States, 91016
Contact: Ajay Goel, PhD    626-218-3452    AJGOEL@COH.ORG   
Principal Investigator: Ajay Goel         
Sub-Investigator: Stanley Hamilton         
Sub-Investigator: Vincent Chung         
Sub-Investigator: Caiming Xu         
Sub-Investigator: Alessandro Mannucci         
Hoag Center Recruiting
Newport Beach, California, United States, 92663
Contact: Michael Demeure       michael.demeure@hoag.org   
Sub-Investigator: Michael Demeure         
United States, Illinois
OSF HealthCare Recruiting
Peoria, Illinois, United States, 61637
Contact: Chandler Wilfong       chandler.d.wilfong@osfhealthcare.org   
Sub-Investigator: Chandler Wilfong         
United States, Louisiana
Ochsner Medical Center Recruiting
Jefferson, Louisiana, United States, 70121
Contact: John Bolton       jbolton@ochsner.org   
Sub-Investigator: John Bolton         
United States, New Jersey
Atlantic Health System Recruiting
Morristown, New Jersey, United States, 07960
Contact: Angela Alistar       angela.alistar@atlantichealth.org   
Sub-Investigator: Angela Alistar         
Sub-Investigator: Eric Whitman         
United States, South Carolina
Piedmont Medical Center Recruiting
Rock Hill, South Carolina, United States, 29732
Contact: Andrew Page       Andrew.Page@piedmont.org   
Sub-Investigator: Andrew Page         
Sub-Investigator: Eyal Meiri         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Douglas Evans       devans@mcw.edu   
Sub-Investigator: Douglas Evans         
Japan
Nagoya University Recruiting
Nagoya, Japan
Contact: Yasuhiro Kodera       ykodera@med.nagoya-u.ac.jp   
Sub-Investigator: Yasuhiro Kodera         
Sub-Investigator: Masamichi Hayashi         
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Song Cheol Kim       drksc@amc.seoul.kr   
Sub-Investigator: Song Cheol Kim         
Sponsors and Collaborators
City of Hope Medical Center
Investigators
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Principal Investigator: Ajay Goel, PhD City of Hope Medical Center
More Information
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Publications of Results:

Other Publications:

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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT06388967    
Other Study ID Numbers: 19288/PCDC
First Posted: April 29, 2024    Key Record Dates
Last Update Posted: April 29, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by City of Hope Medical Center:
Micro RNA
Exosome
Cell free
Early detection
Screening
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases