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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01653002
First Posted: July 30, 2012
Last Update Posted: October 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Epigenomics, Inc
Information provided by (Responsible Party):
Kaid Darwiche, University Hospital, Essen
  Purpose
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.

Condition Intervention
Lung Cancer With Mediastinal Lymph Node Involvement Other: No intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Kaid Darwiche, University Hospital, Essen:

Primary Outcome Measures:
  • Diagnostic Performance of SHOX2 [ Time Frame: one Year ]
    Diagnostic performance of SHOX2 methylation Level as biomarker for lung cancer compared to histologic evaluation of EBUS-TBNA specimen alone.


Enrollment: 200
Study Start Date: February 2012
Study Completion Date: June 2014
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lung cancer with lymph node involvement Other: No intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with proven or suspcted lung cancer and enlarged mediastinal or hilar lymph nodes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • clinical condition which excludes general anesthesia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653002


Locations
Germany
Ruhrlandklinik - Universitätsklinikum Essen
Essen, Germany, 45239
Sponsors and Collaborators
University Hospital, Essen
Epigenomics, Inc
  More Information

Responsible Party: Kaid Darwiche, Dr. med. Kaid Darwiche, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT01653002     History of Changes
Other Study ID Numbers: RLK-Epi-1
11-4921-BO ( Other Identifier: Ethical Review Board University Clinic Essen )
First Submitted: July 23, 2012
First Posted: July 30, 2012
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Kaid Darwiche, University Hospital, Essen:
Lung cancer
EBUS-TBNA
Epigenetics
shox2 protein, human

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases