Blood-based DNA methylation signatures in cancer: A systematic review.
Yongzheng Li, Zhiyao Fan, Yufan Meng...
https://pubmed.ncbi.nlm.nih.gov/36270476Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID07008664
Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Lung Cancer
Led by University of Maryland, Baltimore · Updated on 2025-06-11
750
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
E
EPOCH Epigenetics, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a new blood test process to diagnose lung cancer by detecting DNA changes. This research aims to validate an epigenetic assay that analyzes DNA methylation signatures from blood samples. The study includes multiple patient groups, such as those with lung cancer (with or without chemotherapy), at-risk individuals undergoing lung screening, and control groups with or without other diseases. The study is observational and seeks to improve lung cancer diagnosis. The study involves collecting up to 15 ml of blood from participants at various times over about five years during their normal clinic visits. Blood samples will be used to extract DNA and analyze epigenetic markers by PCR or next-generation sequencing. The study includes three phases: development, finalization, and validation of the epigenetic signature assay. Participants fall into five groups based on lung cancer status and health conditions. Participants will provide blood samples throughout the study and complete questionnaires about their health and quality of life. Their medical records will also be reviewed by study personnel. The main outcomes include identifying tumor-associated DNA methylation patterns and validating the testing technology over five years. Safety and health-related quality of life will be monitored using standardized questionnaires. Participation lasts approximately five years.
CONDITIONS
Brief Title
Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Lung Cancer
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 5 years
Participants provide blood samples for epigenetic signature assay development and validation.
Blood samples collected at various time points throughout participation
Long-term Monitoring
Duration - Up to 5 years
Participants complete quality of life questionnaires and are monitored over time to assess lung cancer status and assay validation.
Annual visits for assessments and questionnaires
Trial Site Locations
Total: 1 location
1
University of Maryland Baltimore Washington Medical Center
Glen Burnie, Maryland, United States, 21061
Actively Recruiting
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Research Team
M
McKenzie Bedra, MPH
J
Jennifer Emel, MA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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https://pubmed.ncbi.nlm.nih.gov/36788585Methylation biomarkers for early cancer detection and diagnosis: Current and future perspectives.
Joe Ibrahim, Marc Peeters, Guy Van Camp...
https://pubmed.ncbi.nlm.nih.gov/36427394A Novel CpG Methylation Risk Indicator for Predicting Prognosis in Bladder Cancer.
Yufeng Guo, Jianjian Yin, Yuanheng Dai...
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Yan Xie, Peilong Li, Dong Sun...
https://pubmed.ncbi.nlm.nih.gov/37602818A multiplex blood-based assay targeting DNA methylation in PBMCs enables early detection of breast cancer.
Tiantian Wang, Peilong Li, Qiuchen Qi...
https://pubmed.ncbi.nlm.nih.gov/37550304