Health TrialsbyHealthPanel

Pancreatic Cancer Detection Consortium

ConditionsPancreatic CancerPancreatic CarcinomaPancreatic AdenocarcinomaPancreatic Ductal AdenocarcinomaPancreatic NeoplasmsPancreatic Cancer Stage IPancreatic Cancer StagePancreatic Cancer ResectablePancreatic Cancer Stage 0Pancreatic Cancer Stage IIPancreatic Cancer Stage IIIPancreatic Cancer, AdultPancreatic Cancer Non-resectable
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Lack of written informed consent.

Trial population

Independent cohorts of individuals with and without pancreatic cancer (cases and controls, respectively)

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • PANcreatic cancer Exosome Early detectiON (PANXEON)

    Diagnostic test

    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

Treatment groups

2,000 Participants
are divided into 4 treatment groups
Group A: Patients with Pancreatic Cancer Ductal Adenocarcinoma (Training)1 intervention
Group B: Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Training)1 intervention
Group C: Patients with Pancreatic Cancer Ductal Adenocarcinoma (Validation)1 intervention
Group D: Individuals without Pancreatic Cancer Ductal Adenocarcinoma (Validation)1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity

True positive rate: the probability of a positive test result, conditioned on the individual truly being positive

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Specificity

True negative rate: the probability of a negative test result, conditioned on the individual truly being negative

Time frame
Through study completion, an average of 1 year
2

Accuracy

A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City of Hope Medical Center

Lead sponsor

Source ClinicalTrials.gov
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