Pancreatic Cancer Detection Consortium

Pancreatic Cancer Clinical Trial

— PCDC  

Official title:

Early Detection of Pancreatic Cancer: Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06388967
• Other study ID #: 19288/PCDC
• Status: Recruiting
• Start date: March 15, 2023
• Est. completion date: November 21, 2025

Study information

• Verified date: April 2024
• Source: City of Hope Medical Center
• Contact: Ajay Goel, PhD
• Phone: 6262183452
• Email: AJGOEL[@]COH.ORG
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: November 21, 2025
• Est. primary completion date: November 21, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Cancer Non-resectable
• Pancreatic Cancer Resectable
• Pancreatic Cancer Stage
• Pancreatic Cancer Stage II
• Pancreatic Cancer Stage III
• Pancreatic Cancer, Adult
• Pancreatic Carcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Japan	Nagoya University	Nagoya
Korea, Republic of	Asan Medical Center	Seoul
United States	Ochsner Medical Center	Jefferson	Louisiana
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	City of Hope Medical Center	Monrovia	California
United States	Atlantic Health System	Morristown	New Jersey
United States	Hoag Center	Newport Beach	California
United States	OSF HealthCare	Peoria	Illinois
United States	Translational Genomics Research Institute	Phoenix	Arizona
United States	Piedmont Medical Center	Rock Hill	South Carolina
United States	Honorhealth	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
City of Hope Medical Center

Countries where clinical trial is conducted

United States,  Japan,  Korea, Republic of, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	True positive rate: the probability of a positive test result, conditioned on the individual truly being positive	Through study completion, an average of 1 year
Secondary	Specificity	True negative rate: the probability of a negative test result, conditioned on the individual truly being negative	Through study completion, an average of 1 year
Secondary	Accuracy	A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined	Through study completion, an average of 1 year