ExoLuminate Study for Early Detection of Pancreatic Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBiological Dynamics
About this trial
ExoLuminate is a nationally-enrolling registry study designed for earlier detection of cancer in patients at elevated risk or clinically-suspicious for pancreatic ductal adenocarcinoma (PDAC).
Those with elevated risk for PDAC can include individuals with intraductal papillary mucinous neoplasms, family history of pancreatic cancer, germline mutations in genes known to be associated with cancer, and a personal or family history of pancreatitis.
The goal of the study is to compare the performance of ExoVerita™ assay in early detection of PDAC to current standard-of-care methods of surveillance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old.
Meeting criteria for one of the study cohorts.
Capable of giving informed consent.
Able to provide a blood sample.
Disqualifiers
< 18 years old.
Pregnancy.
Active cancer (other than pancreatic cancer) and/or undergoing treatment for an active cancer diagnosis (except for skin malignancies).
Prior organ transplant or bone marrow transplant.
Trial population
Individuals at high risk of pancreatic cancer or with stage I-II pancreatic cancer (or clinical suspicion). See cohorts under Groups and Interventions for details.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 8 trial groups8
Trial groupsSee each trial group below.
Group A: Cohort 1
Group B: Cohort 2
Group C: Cohort 3
Group D: Cohort 4
Group E: Cohort 5 - Personal history of PDAC
Group F: Cohort 6 - Pancreatic cysts
Group G: Cohort 7 - Acute or chronic pancreatitis
Group H: Cohort 8 - PDAC stages I-II or clinical suspicion
Trial outcomes
Primary outcomes
1
Clinical performance of ExoVerita™ assay
Specificity
Time frame
36 months or until diagnostic resolutionSecondary outcomes
1
Clinical performance of ExoVerita™ assay
Sensitivity
Time frame
36 months or until diagnostic resolution2
Stage Shift
Evaluation of stage distribution (SEER) at diagnosis
Time frame
36 months or until diagnostic resolutionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov