Clinical trial NCT06388967: Pancreatic Cancer Detection Consortium
Official title: Early Detection of Pancreatic Cancer: Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: 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
Keywords: Micro RNA
Exosome
Cell free
Early detection
Screening
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Independent cohorts of individuals with and without pancreatic cancer (cases and controls, respectively)

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

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.

Eligibility 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.

Primary outcomes:
measure: Sensitivity
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Specificity
timeFrame: Through study completion, an average of 1 year
measure: Accuracy
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Translational Genomics Research Institute
state: Arizona
city: Scottsdale
country: United States
facility: Honorhealth
state: Arizona
city: Monrovia
country: United States
facility: City of Hope Medical Center
state: California
city: Newport Beach
country: United States
facility: Hoag Center
state: California
city: Peoria
country: United States
facility: OSF HealthCare
state: Illinois
city: Jefferson
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: Rock Hill
country: United States
facility: Piedmont Medical Center
state: South Carolina
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Nagoya
country: Japan
facility: Nagoya University
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: City of Hope Medical Center
name: Ajay Goel, PhD
role: PRINCIPAL_INVESTIGATOR
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