Pancreatic Cancer Detection Consortium (PCDC)

City of Hope

Status: Enrolling

Conditions: Pancreatic Cancer Non-resectable; Pancreatic Cancer Stage III; Pancreatic Cancer, Adult; Pancreatic Adenocarcinoma; Pancreatic Cancer Stage 0; Pancreatic Ductal Adenocarcinoma; Pancreatic Cancer Stage I; Pancreatic Cancer Stage II; Pancreatic Cancer Resectable; Pancreatic Cancer Stage; Pancreatic Neoplasms; Pancreatic Carcinoma; Pancreatic Cancer

Treatments: Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)

Study type: Observational

Funder types: Other

Identifiers

NCT06388967

19288/PCDC

Details and patient eligibility

About

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

Full 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 identifying PDAC at its earliest stages.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,000 participants in 4 patient groups

Patients with Pancreatic Cancer Ductal Adenocarcinoma (Training)

Description:

Individuals diagnosed with pancreatic ductal adenocarcinoma

Treatment:

Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)

Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Training)

Description:

Individuals without pancreatic ductal adenocarcinoma

Treatment:

Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)

Patients with Pancreatic Cancer Ductal Adenocarcinoma (Validation)

Description:

Individuals diagnosed with pancreatic ductal adenocarcinoma

Treatment:

Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)

Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Validation)

Description:

Individuals without pancreatic ductal adenocarcinoma

Treatment:

Diagnostic Test: PANcreatic cancer Exosome Early detectiON (PANXEON)