SHOX2_PTGER4 DNA Methlyation in Lung Cancer | NCT04321499

Studies
SHOX2_PTGER4 DNA Methlyation in Lung Cancer

NCT04321499

Sponsor

University Hospital, Essen

Status

Completed

Last Update Posted

Mar 25, 2020Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Lungcancer

Interventions

lung cancer

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2017Actual

First Submitted Date

Mar 23, 2020

First Submission Date that Met QC Criteria

Mar 23, 2020

First Posted Date

Mar 25, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2020

Last Update Posted Date

Mar 25, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kaid Darwiche, Priv.-Doz. Dr. med. Kaid Darwiche, head of department of interventional pneumology, University Hospital, EssenPrincipal Investigator

Lead Sponsor

University Hospital, EssenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung cancer diagnosis.

A total of 150 patients will be enrolled in this study. SHOX2 and PTGER4 will be analyzed via PCR of blood plasma samples.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
lung cancer	Genetic	PCR for SHOX2 and PTGER4	benign nodules lung cancer

Measure	Description	Time Frame
DNA Methylation at early stages of lung cancer		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

suspicious finding for lung cancer on CT-scan

Exclusion Criteria:

history significant for former malignant diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

lung cancer, benign nodule

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kaid Darwiche, MD	head of deparment of interventional pneumology, Ruhrlandklinik, UHEssen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruhrlandklinik, Department of Interventional Pneumology		Essen	North Rhine-Westphalia	45239	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27544059	Background	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.