Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Pancreatic Cancer

Part of paid clinical trials in Glen Burnie, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07528430
Status
Not Yet Recruiting

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Conditions

  • Pancreatic Cancer, Advanced or Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The purpose of this research study is to test a new process for diagnosing pancreatic cancer by examining changes to your DNA that can be detected from a blood test. The information we learn by doing this study could potentially help people in the future. Participants in this study will have blood samples collected, have their medical records reviewed by study personnel and fill out questionnaires at different time points during the study. Blood sample collection will occur during normal routine clinic visits. Participation in this study will last approximately 5 years.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2032
Completion
Jul 31, 2032

Study Design

Enrollment
450 participants (estimated)

Arms

  • Arm: Study Population 1
    This study population will consist of individuals who have a diagnosis of pancreatic cancer and have not received chemotherapy treatment for their pancreatic cancer. Individuals who have received surgical resection and/or radiation therapy for their pancreatic cancer will be included.
  • Arm: Study Population 2
    This study population will consist of individuals who have a diagnosis of pancreatic cancer and have received chemotherapy treatment for their pancreatic cancer. All stages of pancreatic cancer will be included including individuals in remission.
  • Arm: Study Population 3
    This study population will consist of individuals who are at high risk of developing pancreatic cancer.

Primary Outcome Measure

Identification of tumor-associated host methylation signature [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Baltimore Washington Medical CenterGlen BurnieMaryland21061
Peter Olivieri, MD
[email protected]
410-553-8241
Jeffrey Marshall, MD (SUB_INVESTIGATOR)
Harvinder Singh, MD (SUB_INVESTIGATOR)
Agazi Gebreselassie, MD (SUB_INVESTIGATOR)

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By research site
University of Maryland Baltimore Washington Medical Center· Glen Burnie, MD

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