Lung Cancer Screening Using DNA Methylation Changes in Circulated Tumor and PBMC DNA

Terminated

• Conditions: Lung Cancer, Nonsmall Cell; Lung Cancer; Lung Cancer, Small Cell

• Registration Number: NCT03499678
• Lead Sponsor: HKGepitherapeutics

Brief Summary

A central challenge in the fight against lung cancers is how to detect disease in a noninvasive manner before it is detectable by imaging methods. Although inroads have been made with more sensitive imaging techniques for earlier detection of breast and lung cancers, these techniques are limited by the size of lesion that could be detected. Alternatively, several blood proteomic biomarkers have been proposed but none offer as of yet sufficient predictive power. Consequently, effective non-invasive tools as prognostic indicators and biomarkers of lung cancer is urgently needed.

The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in lung cancer patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-28
• Study First Submitted QC: 2018-04-13
• Study First Posted: 2018-04-17
• Study Start: 2018-07-01
• Primary Completion: 2019-07-19
• Study Completion: 2019-07-19
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Histological confirmed lung cancer

Exclusion Criteria

• Pregnant women
• Minors (subjects less than 18 years of age)
• Prisoners
• Patients with known infectious disease, such as human immunodeficiency virus (HIV), tuberculosis (TB), or hepatitis B, C
• Patients having other than one cancer
• Subjects unable to consent for themselves

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of lung cancer	6 months to 1 year	The outcome is the methylation score, which combines the weighted methylation values of four CpGs. A threshold methylation score that differentiates between control and cancer individuals will be calculated from the training set of 100 patients.; The model will be provided to the researchers: Methylation score=CG1\*b1+CG2\*b2+ CG3\*b3+ CG4\*b4 + e; CG1 is the methylation value of the first CG b1 is the regression coefficient for the first CG and "e" equals the intercept. Investigators will develop the regression coefficient and intercept as well as the DNA methylation values for each patient for each CG. Investigators will first compute the polygenic methylation score for each patient. Then based on the computer threshold based on the training cohort will call the samples as lung cancer or not.

Trial Locations

Locations (1)

Kazakh Institute of Oncology and Radiology; 🇰🇿 Almaty, Kazakhstan