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RecruitingObservational

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

NCT ID: NCT07008664Sponsor: University of Maryland, BaltimoreLast updated: 2025-06-11

Summary

The purpose of this research study is to test a new process for diagnosing lung 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.

Detailed description

This clinical testing research study outlines the validation process for an epigenetic assay targeting host peripheral blood cell and the associated host DNA methylation signatures designed to diagnose lung cancer. The overall protocol process will involve three distinct stages representing three patient cohorts with up to 250 subjects per cohort across 5 populations of patients. Cohort one will act as signature development phase; cohort two will act as signature finalization phase; and cohort three will act as a validation cohort phase. Each cohort will include the following patient populations with up to 50 patients per population: 1. Lung cancer; No chemotherapy. Surgical resection or stereotactic body radiation therapy (SBRT) only 2. Lung cancer; With chemotherapy. All stages including remission 3. At risk group (Lung cancer screening population) 4. Control group with mixed comorbid disease EXCLUDING tobacco use of greater than 10 pack years (PY) or chronic obstructive pulmonary disease (COPD) 5. Healthy controls with no comorbid disease

Arms & interventions

  • OtherEpigenetic Signature Assay

    Up to 15 ml of blood will be collected from each patient at various time points throughout their 5 years of participation. DNA extraction, bisulfite conversion and analysis of epigenetic markers through PCR or next-generation sequencing will be performed. An epigenetic signature assay will then be identified.

Outcome measures

Primary

  • Identification of tumor-associated host methylation signature

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

    Time frame: 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.

    Time frame: 5 years

  • Technology validation

    The investigators will validate identified blood-based circulating methylation signatures in patients with undiagnosed pulmonary nodules.

    Time frame: 1 year

Secondary

  • EORTC QLQ-C30 Questionnaire

    Time frame: 5 years

  • EORTC QLQ-LC13 Questionnaire

    Time frame: 5 years

  • SF-36v2 Questionnaire

    Time frame: 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes
Inclusion Criteria: * 18 years old or older * Patient at University of Maryland Baltimore Washington Medical Center * Willing and able to consent to study procedures listed in the protocol * Ability to speak and understand English Exclusion Criteria: * Younger than 18 years old * Patient not cared for at University of Maryland Baltimore Washington Medical Center * Unable to consent to study procedures listed in the protocol * Unable to speak or understand English

Study locations (1)

University of Maryland Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061

Recruiting
Jeffrey Marshall, MD · Contact
410-787-4000Jeffrey.Marshall@umm.edu
Jeffrey Marshall, MD · Principal Investigator
Peter Olivieri, MD · Sub Investigator
Darwin Ashbaker, MD · Sub Investigator

References

  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)