SHOX2_PTGER4 DNA Methlyation in Lung Cancer

Overview

Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung cancer diagnosis.

In this study a control group consisting of COPD patients with a CT-scan of the chest no older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of lung cancer will be included.

SHOX2 and PTGER4 will be analyzed via PCR.

Full Title of Study: “Establishing a Non-invasive Diagnostic Biomarker Test for Early Diagnosis of Lung Cancer”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: March 2017

Detailed Description

Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung cancer diagnosis.

In this study a control group consisting of COPD patients with a CT-scan of the chest no older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of lung cancer will be included.

A total of 150 patients will be enrolled in this study. SHOX2 and PTGER4 will be analyzed via PCR of blood plasma samples.

Interventions

  • Genetic: lung cancer
    • PCR for SHOX2 and PTGER4

Arms, Groups and Cohorts

  • lung cancer
    • stage IA-IIIA lung cancer
  • benign nodules
    • ruled out lung cancer via Operation or CT-scan follow-up

Clinical Trial Outcome Measures

Primary Measures

  • DNA Methylation at early stages of lung cancer
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

suspicious finding for lung cancer on CT-scan

Exclusion Criteria

  • history significant for former malignant diseases

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 95 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Essen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kaid Darwiche, Priv.-Doz. Dr. med. Kaid Darwiche, head of department of interventional pneumology – University Hospital, Essen
  • Overall Official(s)
    • Kaid Darwiche, MD, Principal Investigator, head of deparment of interventional pneumology, Ruhrlandklinik, UHEssen

References

Weiss G, Schlegel A, Kottwitz D, K├Ânig T, Tetzner R. Validation of the SHOX2/PTGER4 DNA Methylation Marker Panel for Plasma-Based Discrimination between Patients with Malignant and Nonmalignant Lung Disease. J Thorac Oncol. 2017 Jan;12(1):77-84. doi: 10.1016/j.jtho.2016.08.123. Epub 2016 Aug 18.

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