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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital, Essen
Sponsor:
Collaborator:
Epigenomics, Inc
Information provided by (Responsible Party):
Kaid Darwiche, University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT01653002
First received: July 23, 2012
Last updated: May 21, 2014
Last verified: May 2014
  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 University Hospital, Essen:

Primary Outcome Measures:
  • Diagnostic Performance of SHOX2 [ Time Frame: one Year ] [ Designated as safety issue: No ]
    Diagnostic performance of SHOX2 methylation Level as biomarker for lung cancer compared to histologic evaluation of EBUS-TBNA specimen alone.


Estimated Enrollment: 200
Study Start Date: February 2012
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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653002

Contacts
Contact: Kaid Darwiche, MD +49201433 ext 4219 kaid.darwiche@ruhrlandklinik.uk-essen.de

Locations
Germany
Ruhrlandklinik - Universitätsklinikum Essen Recruiting
Essen, Germany, 45239
Contact: Kaid Darwiche, MD    +49201433 ext 4219    kaid.darwiche@ruhrlandklinik.uk-essen.de   
Principal Investigator: Kaid Darwiche, MD         
Principal Investigator: Lutz Freitag, MD         
Sponsors and Collaborators
University Hospital, Essen
Epigenomics, Inc
  More Information

No publications provided

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
Study First Received: July 23, 2012
Last Updated: May 21, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on July 22, 2014