RECRUITING

ExoLuminate Study for Early Detection of Pancreatic Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Exoluminate Study: Observational Registry Study to Assess Exo-PDAC Assay Performance for Detection of Pancreatic Adenocarcinoma (PDAC) in High-Risk or Clinically Suspicious Patients

Quick Facts

Study Start:2022-12-19
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05625529

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years old.
  2. * Meeting criteria for one of the study cohorts.
  3. * Capable of giving informed consent.
  4. * Able to provide a blood sample.
  1. * \< 18 years old.
  2. * Pregnancy.
  3. * Active cancer (other than pancreatic cancer) and/or undergoing treatment for an active cancer diagnosis (except for skin malignancies).
  4. * Prior organ transplant or bone marrow transplant.
  5. * History of fainting or other adverse effects when blood is drawn.
  6. * Any condition that, in the opinion of the investigator, should preclude enrollment.

Contacts and Locations

Study Contact

Harmeet Dhani, MD, M.Sc
CONTACT
858-202-6150
exoluminate@biologicaldynamics.com

Principal Investigator

Harmeet Dhani, MD, M.Sc
PRINCIPAL_INVESTIGATOR
Biological Dynamics

Study Locations (Sites)

University of California, San Diego
La Jolla, California, 92093
United States
Biological Dynamics
San Diego, California, 92121
United States
Saint John's Cancer Institute at Providence Saint John's Health Center
Santa Monica, California, 90404
United States
Dr. Lomis Comprehensive Surgical Center
Van Nuys, California, 91405
United States
MedStar Health Research Institute
Washington, District of Columbia, 20010
United States
University of Florida
Gainesville, Florida, 32610
United States
Bhanu Visvalingam
Port Orange, Florida, 32127
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02136
United States

Collaborators and Investigators

Sponsor: Biological Dynamics

  • Harmeet Dhani, MD, M.Sc, PRINCIPAL_INVESTIGATOR, Biological Dynamics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-19
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2022-12-19
Study Completion Date2027-01-01

Terms related to this study

Keywords Provided by Researchers

  • Early Detection
  • Exosomes
  • Extracellular Vesicles
  • IPMN
  • PDAC
  • Pancreatic Cancer

Additional Relevant MeSH Terms

  • Pancreas Cancer
  • Exosomes
  • Extracellular Vesicles
  • Pancreatic Neoplasms