LungcancerEpi1NCT04321499
SHOX2_PTGER4 DNA Methlyation in Lung Cancer
An observational study of Lungcancer, run by University Hospital, Essen at 1 site in Germany.
Trial summary
Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung cancer diagnosis. In this study a control group consisting of COPD patients with a CT-scan of the chest no older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of lung cancer will be… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Lungcancer
- What is being tested?
- lung cancer
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Mar 2017
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: lung cancer, benign nodule
Who may be able to join
- suspicious finding for lung cancer on CT-scan
Who cannot join
- history significant for former malignant diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Ruhrlandklinik, Department of Interventional Pneumology
Essen, North Rhine-Westphalia, 45239
About this study
Official title: Establishing a Non-invasive Diagnostic Biomarker Test for Early Diagnosis of Lung Cancer
Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung cancer diagnosis.
In this study a control group consisting of COPD patients with a CT-scan of the chest no older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of lung cancer will be included.
SHOX2 and PTGER4 will be analyzed via PCR.
Read the detailed description
Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung cancer diagnosis.
In this study a control group consisting of COPD patients with a CT-scan of the chest no older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of lung cancer will be included.
A total of 150 patients will be enrolled in this study. SHOX2 and PTGER4 will be analyzed via PCR of blood plasma samples.
- Conditions
- Lungcancer
- Being tested
- lung cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung cancerGenetic
PCR for SHOX2 and PTGER4
| Study group | Role | What they receive |
|---|---|---|
| lung cancer | stage IA-IIIA lung cancer Receives: Genetic: lung cancer | |
| benign nodules | ruled out lung cancer via Operation or CT-scan follow-up Receives: Genetic: lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA Methylation at early stages of lung cancer
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study startMay 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LungcancerStudies 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
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaid Darwiche, University Hospital, Essen
- Investigators
- Kaid Darwiche, MD, Principal investigator, head of deparment of interventional pneumology, Ruhrlandklinik, UHEssen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321499
- Sponsor's protocol ID
- SHOX2 and PTGER4
- Acronym
- Epi1
- Status last verified
- Mar 2020
- First submitted
- 23 Mar 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Weiss G, Schlegel A, Kottwitz D, Konig T, Tetzner R. Validation of the SHOX2/PTGER4 DNA Methylation Marker Panel for Plasma-Based Discrimination between Patients with Malignant and Nonmalignant Lung Disease. J Thorac Oncol. 2017 Jan;12(1):77-84. doi: 10.1016/j.jtho.2016.08.123. Epub 2016 Aug 18.
PubMed 27544059
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Non-invasive Diagnostic Biomarker Test for Early Diagnosis of Lung Cancer
- ClinicalTrials.gov ID
- NCT04321499
- Acronym / sponsor ID
- Epi1 / SHOX2 and PTGER4
- Conditions
- Lungcancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 25 Mar 2020 (actual)
- 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.
Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung cancer diagnosis.
In this study a control group consisting of COPD patients with a CT-scan of the chest no older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of lung cancer will be included.
SHOX2 and PTGER4 will be analyzed via PCR.
Detailed description
Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung cancer diagnosis.
In this study a control group consisting of COPD patients with a CT-scan of the chest no older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of lung cancer will be included.
A total of 150 patients will be enrolled in this study. SHOX2 and PTGER4 will be analyzed via PCR of blood plasma samples.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lung cancer | – | Genetic: lung cancerstage IA-IIIA lung cancer |
| benign nodules | – | Genetic: lung cancerruled out lung cancer via Operation or CT-scan follow-up |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- lung cancer, benign nodule
Key inclusion criteria (1 listed)
- suspicious finding for lung cancer on CT-scan
Key exclusion criteria (1 listed)
- history significant for former malignant diseases
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 |
|---|---|---|
| lung cancerPCR for SHOX2 and PTGER4 | Genetic | benign nodules, lung cancer |
Primary outcome
DNA Methylation at early stages of lung cancer
Time frame: 1 year
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 25 Mar 2020.
- Background: PubMed 27544059Weiss G, Schlegel A, Kottwitz D, Konig T, Tetzner R. Validation of the SHOX2/PTGER4 DNA Methylation Marker Panel for Plasma-Based Discrimination between Patients with Malignant and Nonmalignant Lung Disease. J Thorac Oncol. 2017 Jan;12(1):77-84. doi: 10.1016/j.jtho.2016.08.123. Epub 2016 Aug 18.
- Individual participant dataSharing planned: No
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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.
Kaid Darwiche, MD principal investigator
head of deparment of interventional pneumology, Ruhrlandklinik, UHEssen
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 Lungcancer, 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 1 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 25 Mar 2020. 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?
DNA Methylation at early stages of lung cancer (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04321499, which also lists 1 linked publication.
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 25 Mar 2020.