Methylation Level of SHOX2 in Endobronchial Ultrasound With Real-time Guided Transbronchial Needle Aspiration for Lung Cancer Staging

Completed

• Conditions: Lung Cancer With Mediastinal Lymph Node Involvement
• Interventions: Other: No intervention

• Registration Number: NCT01653002
• Lead Sponsor: University Hospital, Essen

Brief Summary

A DNA hypermethylation of the gene locus SHOX2 can be frequently found in lung cancer tissue. The purpose of this study is to determine whether the assessment of the hypermethylation level of SHOX2 in specimens obtained by endosonographic guided bronchoscopy makes a contribution to lung cancer staging.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-02
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-27
• Study First Posted: 2012-07-30
• Study Completion: 2014-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• clinical diagnosis of lung cancer
• enlarged mediastinal or hilar lymph nodes (>10 mm)

Exclusion Criteria

• clinical condition which excludes general anesthesia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung cancer with lymph node involvement	No intervention	-

Primary Outcome Measures

Name	Time	Method
Diagnostic Performance of SHOX2	one Year	Diagnostic performance of SHOX2 methylation Level as biomarker for lung cancer compared to histologic evaluation of EBUS-TBNA specimen alone.

Trial Locations

Locations (1)

Ruhrlandklinik - Universitätsklinikum Essen; 🇩🇪 Essen, Germany