Epi1: SHOX2_PTGER4 DNA Methlyation in Lung Cancer

• Sponsor: University Hospital, Essen (Other)
• Overall Status: Completed
• CT.gov ID: NCT04321499
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Actual Duration (Months): 10
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lungcancer	Genetic: lung cancer

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 70 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Establishing a Non-invasive Diagnostic Biomarker Test for Early Diagnosis of Lung Cancer
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
lung cancer stage IA-IIIA lung cancer	Genetic: lung cancer; PCR for SHOX2 and PTGER4
benign nodules ruled out lung cancer via Operation or CT-scan follow-up	Genetic: lung cancer; PCR for SHOX2 and PTGER4

Outcome Measures

Primary Outcome Measures

1. DNA Methylation at early stages of lung cancer [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 95 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

suspicious finding for lung cancer on CT-scan

Exclusion Criteria:

• history significant for former malignant diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruhrlandklinik, Department of Interventional Pneumology	Essen	NRW	Germany	45239

Sponsors and Collaborators

• University Hospital, Essen

Investigators

• Principal Investigator: Kaid Darwiche, MD, head of deparment of interventional pneumology, Ruhrlandklinik, UHEssen

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Kaid Darwiche, Priv.-Doz. Dr. med. Kaid Darwiche, head of department of interventional pneumology, University Hospital, Essen
• ClinicalTrials.gov Identifier: NCT04321499
• Other Study ID Numbers: SHOX2 and PTGER4
• First Posted: Mar 25, 2020
• Last Update Posted: Mar 25, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Mar 25, 2020