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

Lung Cancer Clinical Trial

Official title:

Clinical Trials on Detection of Lung Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03499678
• Other study ID #: HKG-KZ-LNG-102
• Status: Terminated
• Start date: July 1, 2018
• Est. completion date: July 19, 2019

Study information

• Verified date: December 2023
• Source: HKGepitherapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 81
• Est. completion date: July 19, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Cancer, Nonsmall Cell
• Lung Cancer, Small Cell
• Lung Neoplasms
• Small Cell Lung Carcinoma

Locations

Country	Name	City	State
Kazakhstan	Kazakh Institute of Oncology and Radiology	Almaty

Sponsors (2)

Lead Sponsor	Collaborator
HKGepitherapeutics	Kazakh Research Institute of Oncology & Radiology

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of lung cancer	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.	6 months to 1 year