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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03499678
Recruitment Status : Terminated (Technical problem with blood plasma samples obtained from the hospital.)
First Posted : April 17, 2018
Last Update Posted : April 20, 2022
Kazakh Research Institute of Oncology & Radiology
Information provided by (Responsible Party):

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
Lung Cancer Lung Cancer, Nonsmall Cell Lung Cancer, Small Cell

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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 : July 1, 2018
Actual Primary Completion Date : July 19, 2019
Actual Study Completion Date : July 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Lung Cancer
Small cell lung cancers (SCLC) and non-small cell lung cancers (NSCLC)
Age and sex matched control individuals

Primary Outcome Measures :
  1. DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of lung cancer [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA
DNA extracted from PBMC

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients will be assigned an ID that will be kept confidential according to hospital regulations. IDs will be randomized so that identity will not be revealed except to the approved hospital personnel. Methylation data will be returned to the hospital for follow up of progression of disease and for assessing early prediction of progression of lung cancer and will be entered into the data base. Other clinical follow up data will be entered into the electronic data base. All data will be captured in case report form.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03499678

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Kazakh Institute of Oncology and Radiology
Almaty, Kazakhstan
Sponsors and Collaborators
Kazakh Research Institute of Oncology & Radiology
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Responsible Party: HKGepitherapeutics Identifier: NCT03499678    
Other Study ID Numbers: HKG-KZ-LNG-102
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms