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

NCT03499678 | Terminated

• 1 other identifier: HKG-KZ-LNG-102
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Lung Cancer

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

Control

Age and sex matched control individuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Histological confirmed lung cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• HKGepitherapeutics: lead
• Kazakh Research Institute of Oncology & Radiology: collaborator

Study Sites (1)

Kazakh Institute of Oncology and Radiology

Almaty, Kazakhstan

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA extracted from PBMC

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: April 17, 2018
• Study Start: July 1, 2018
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

KA (1)