SHOX2_PTGER4 DNA Methlyation in Lung Cancer

Lungcancer Clinical Trial

— Epi1  

Official title:

Establishing a Non-invasive Diagnostic Biomarker Test for Early Diagnosis of Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04321499
• Other study ID #: SHOX2 and PTGER4
• Status: Completed
• Start date: May 2016
• Est. completion date: March 2017

Study information

• Verified date: March 2020
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

suspicious finding for lung cancer on CT-scan

Exclusion Criteria:

• history significant for former malignant diseases

Related Conditions & MeSH terms

• Lung Neoplasms
• Lungcancer

Intervention

Genetic:
• lung cancer
PCR for SHOX2 and PTGER4

Locations

Country	Name	City	State
Germany	Ruhrlandklinik, Department of Interventional Pneumology	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Weiss G, Schlegel A, Kottwitz D, König 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA Methylation at early stages of lung cancer		1 year