Clinical trial NCT07008664: Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Lung Cancer
Official title: Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lung Cancer Screening
Healthy Volunteers (HV)
Unhealthy Volunteers
Keywords: Lung Cancer
Lung Cancer Screening
Healthy Volunteers
Unhealthy Volunteers
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: EPOCH Epigenetics, Inc
First posted: 2025-06-06
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be selected from patients being cared for at the University of Maryland Baltimore Washington Medical Center

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Identification of tumor-associated host methylation signature
timeFrame: 5 years
measure: Technology development
timeFrame: 5 years
measure: Technology validation
timeFrame: 1 year
Secondary outcomes:
measure: EORTC QLQ-C30 Questionnaire
timeFrame: 5 years
measure: EORTC QLQ-LC13 Questionnaire
timeFrame: 5 years
measure: SF-36v2 Questionnaire
timeFrame: 5 years
Other outcomes:
Locations:
city: Glen Burnie
country: United States
facility: University of Maryland Baltimore Washington Medical Center
state: Maryland
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.