NCT04321499

Brief 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 included. SHOX2 and PTGER4 will be analyzed via PCR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 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

May 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

March 23, 2020

Last Update Submit

March 23, 2020

Conditions

Lungcancer

Outcome Measures

Primary Outcomes (1)

  • DNA Methylation at early stages of lung cancer

    1 year

Study Arms (2)

lung cancer

stage IA-IIIA lung cancer

Genetic: lung cancer

benign nodules

ruled out lung cancer via Operation or CT-scan follow-up

Genetic: lung cancer

Interventions

lung cancerGENETIC

PCR for SHOX2 and PTGER4

benign noduleslung cancer

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

lung cancer, benign nodule

You may qualify if:

  • suspicious finding for lung cancer on CT-scan

You may not qualify if:

  • history significant for former malignant diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruhrlandklinik, Department of Interventional Pneumology

Essen, North Rhine-Westphalia, 45239, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27544059BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

plasma

Study Officials

  • Kaid Darwiche, MD

    head of deparment of interventional pneumology, Ruhrlandklinik, UHEssen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv.-Doz. Dr. med. Kaid Darwiche, head of department of interventional pneumology

Study Record Dates

First Submitted

March 23, 2020

First Posted

March 25, 2020

Study Start

May 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)