Methylation Level of SHOX2 in Endobronchial Ultrasound With Real-time Guided Transbronchial Needle Aspiration for Lung Cancer Staging
This study is currently recruiting participants.
Verified July 2012 by University Hospital, Essen
Sponsor:
University Hospital, Essen
Collaborator:
Epigenomics, Inc
Information provided by (Responsible Party):
Kaid Darwiche, University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT01653002
First received: July 23, 2012
Last updated: July 27, 2012
Last verified: July 2012
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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
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: | July 27, 2012 |
| 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 May 22, 2013