SHOX2_PTGER4 DNA Methlyation in Lung Cancer (Epi1)

March 23, 2020 updated by: Kaid Darwiche, University Hospital, Essen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Essen, NRW, Germany, 45239
        • Ruhrlandklinik, Department of Interventional Pneumology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

lung cancer, benign nodule

Description

Inclusion Criteria:

suspicious finding for lung cancer on CT-scan

Exclusion Criteria:

  • history significant for former malignant diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Essen

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHOX2 and PTGER4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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