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
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