Lung Cancer With Mediastinal Lymph Node InvolvementNCT01653002
Methylation Level of SHOX2 in Endobronchial Ultrasound With Real-time Guided Transbronchial Needle Aspiration for Lung Cancer Staging
An observational study of Lung Cancer With Mediastinal Lymph Node Involvement, run by University Hospital, Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer With Mediastinal Lymph Node Involvement
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with proven or suspcted lung cancer and enlarged mediastinal or hilar lymph nodes
Who may be able to join
- clinical diagnosis of lung cancer
- enlarged mediastinal or hilar lymph nodes (>10 mm)
Who cannot join
- clinical condition which excludes general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- No intervention
- Keywords
- Lung cancer, EBUS-TBNA, Epigenetics, shox2 protein, human
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Lung cancer with lymph node involvement | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance of SHOX2
Diagnostic performance of SHOX2 methylation Level as biomarker for lung cancer compared to histologic evaluation of EBUS-TBNA specimen alone.
Measured: one Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer With Mediastinal Lymph Node InvolvementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Epigenomics, Inc
- Responsible party
- Principal investigator, Kaid Darwiche, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653002
- Sponsor's protocol ID
- RLK-Epi-1
- Other IDs
- 11-4921-BO
- Status last verified
- Oct 2016
- First submitted
- 23 Jul 2012
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylation Level of SHOX2 in Endobronchial Ultrasound With Real-time Guided Transbronchial Needle Aspiration for Lung Cancer Staging
- ClinicalTrials.gov ID
- NCT01653002
- Acronym / sponsor ID
- RLK-Epi-1
- Keywords
- Lung cancer, EBUS-TBNA, Epigenetics, shox2 protein, human
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- Epigenomics, Inc
- Study start
- Feb 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung cancer with lymph node involvement | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with proven or suspcted lung cancer and enlarged mediastinal or hilar lymph nodes
Key inclusion criteria (2 listed)
- clinical diagnosis of lung cancer
- enlarged mediastinal or hilar lymph nodes (>10 mm)
Key exclusion criteria (1 listed)
- clinical condition which excludes general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | Lung cancer with lymph node involvement |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer With Mediastinal Lymph Node Involvement, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of SHOX2 (time frame: one Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2016.