NCT01653002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

Same day

First QC Date

July 23, 2012

Last Update Submit

October 24, 2016

Conditions

Lung Cancer With Mediastinal Lymph Node Involvement

Keywords

Lung cancerEBUS-TBNAEpigeneticsshox2 protein, human

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Performance of SHOX2

    Diagnostic performance of SHOX2 methylation Level as biomarker for lung cancer compared to histologic evaluation of EBUS-TBNA specimen alone.

    one Year

Study Arms (1)

Lung cancer with lymph node involvement

Other: No intervention

Interventions

No interventionOTHER
Lung cancer with lymph node involvement

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with proven or suspcted lung cancer and enlarged mediastinal or hilar lymph nodes

You may qualify if:

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

You may not qualify if:

  • clinical condition which excludes general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruhrlandklinik - Universitätsklinikum Essen

Essen, 45239, Germany

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Kaid Darwiche

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 30, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2012

Study Completion

June 1, 2014

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

DE(1)