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

NCT ID: NCT03499678

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-07-19

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Lung Cancer

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

No interventions assigned to this group

Control

Age and sex matched control individuals

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kazakh Research Institute of Oncology & Radiology

OTHER

Sponsor Role collaborator

HKGepitherapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kazakh Institute of Oncology and Radiology

Almaty, , Kazakhstan

Site Status

Countries

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Kazakhstan

Other Identifiers

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HKG-KZ-LNG-102

Identifier Type: -

Identifier Source: org_study_id