NCT07528430

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
75mo left

Started Sep 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2032

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2032

Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

6.1 years

First QC Date

April 7, 2026

Last Update Submit

July 27, 2026

Conditions

Pancreatic Cancer, Advanced or Metastatic

Keywords

Pancreatic cancerPancreatic cancer screening

Outcome Measures

Primary Outcomes (3)

  • Identification of tumor-associated host methylation signature

    Genome-wide methylation profile of whole blood from pancreatic cancer patients, pre-cancer patients, patients undergoing therapy, and control subjects.

    5 years

  • Technology development

    The investigators will develop array-based assays using whole-blood samples, focused on disease-specific methylation sites to provide early diagnosis, prognosis, and therapeutic efficacy prediction.

    5 years

  • Technology validation

    The investigators will validate identified blood-based circulating methylation signatures in patients at high risk for developing pancreatic cancer.

    5 years

Study Arms (3)

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.

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.

Study Population 3

This study population will consist of individuals who are at high risk of developing pancreatic cancer.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be selected from patients being cared for across the University of Maryland Medical System

You may qualify if:

  • years old or older
  • Patient of UMMS
  • Willing and able to consent to study procedures listed in the protocol
  • Ability to speak and understand English
  • Has a history of pancreatic cancer of is at high risk for pancreatic cancer

You may not qualify if:

  • Younger than 18 years old
  • Patient not cared for at UMMS
  • Unable to consent to study procedures listed in the protocol
  • Unable to speak or understand English
  • Does not have a history of pancreatic cancer or is not at high risk for pancreatic cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061, United States

Location

Related Publications (6)

  • Li Y, Fan Z, Meng Y, Liu S, Zhan H. Blood-based DNA methylation signatures in cancer: A systematic review. Biochim Biophys Acta Mol Basis Dis. 2023 Jan 1;1869(1):166583. doi: 10.1016/j.bbadis.2022.166583. Epub 2022 Oct 18.

    PMID: 36270476BACKGROUND

  • Terp SK, Stoico MP, Dybkaer K, Pedersen IS. Early diagnosis of ovarian cancer based on methylation profiles in peripheral blood cell-free DNA: a systematic review. Clin Epigenetics. 2023 Feb 14;15(1):24. doi: 10.1186/s13148-023-01440-w.

    PMID: 36788585BACKGROUND

  • Ibrahim J, Peeters M, Van Camp G, Op de Beeck K. Methylation biomarkers for early cancer detection and diagnosis: Current and future perspectives. Eur J Cancer. 2023 Jan;178:91-113. doi: 10.1016/j.ejca.2022.10.015. Epub 2022 Oct 27.

    PMID: 36427394BACKGROUND

  • Guo Y, Yin J, Dai Y, Guan Y, Chen P, Chen Y, Huang C, Lu YJ, Zhang L, Song D. A Novel CpG Methylation Risk Indicator for Predicting Prognosis in Bladder Cancer. Front Cell Dev Biol. 2021 Sep 1;9:642650. doi: 10.3389/fcell.2021.642650. eCollection 2021.

    PMID: 34540821BACKGROUND

  • Xie Y, Li P, Sun D, Qi Q, Ma S, Zhao Y, Zhang S, Wang T, Wang J, Li S, Gong T, Xu H, Xiong M, Li G, You C, Luo Z, Li J, Wang C, Du L. DNA Methylation-Based Testing in Peripheral Blood Mononuclear Cells Enables Accurate and Early Detection of Colorectal Cancer. Cancer Res. 2023 Nov 1;83(21):3636-3649. doi: 10.1158/0008-5472.CAN-22-3402.

    PMID: 37602818BACKGROUND

  • Wang T, Li P, Qi Q, Zhang S, Xie Y, Wang J, Liu S, Ma S, Li S, Gong T, Xu H, Xiong M, Li G, You C, Luo Z, Li J, Du L, Wang C. A multiplex blood-based assay targeting DNA methylation in PBMCs enables early detection of breast cancer. Nat Commun. 2023 Aug 7;14(1):4724. doi: 10.1038/s41467-023-40389-5.

    PMID: 37550304BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Mononuclear Cells (PBMC)

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jennifer Emel, MA

CONTACT

410-553-8048Jennifer.Emel@umm.edu

Sade Bademosi

CONTACT

410-553-8188Sade.Bademosi@umm.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair, Division of Pulmonary & Critical Care; Director, Interventional Pulmonary Program

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

October 1, 2032

Study Completion (Estimated)

November 1, 2032

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)