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

Sponsor
HKGepitherapeutics (Industry)
Overall Status
Terminated
CT.gov ID
NCT03499678
Collaborator
Kazakh Research Institute of Oncology & Radiology (Other)
81
Enrollment
1
Location
12.6
Actual Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    81 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    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
    Actual Study Start Date :
    Jul 1, 2018
    Actual Primary Completion Date :
    Jul 19, 2019
    Actual Study Completion Date :
    Jul 19, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Lung Cancer

    Small cell lung cancers (SCLC) and non-small cell lung cancers (NSCLC)
    Control

    Age and sex matched control individuals

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kazakh Institute of Oncology and Radiology Almaty Kazakhstan

    Sponsors and Collaborators

    • HKGepitherapeutics
    • Kazakh Research Institute of Oncology & Radiology

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    HKGepitherapeutics
    ClinicalTrials.gov Identifier:
    NCT03499678
    Other Study ID Numbers:
    • HKG-KZ-LNG-102
    First Posted:
    Apr 17, 2018
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Small Cell Lung Carcinoma

    Study Results

    No Results Posted as of Apr 20, 2022