- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04467333
Giessen Pulmonary Hypertension in Lung Cancer Registry (PHLHR)
December 4, 2023 updated by: University of Giessen
The aim of this study is to investigate the frequency and implications of pulmonary hypertension in lung cancer patients.
To do so, data will be collected from all lung cancer patients at the university hospital Giessen.
All data will be analyzed for possible hints of pulmonary hypertension as a comorbidity in lung cancer patients.
All information will be generated from the regular guidelines based course of treatment and there will be no interventions.
This study will serve as a prospective register for all lung cancer patients treated at the university hospital Giessen.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bastian Eul, MD
- Phone Number: (+49) 0641/985-42371
- Email: bastian.eul@innere.med.uni-giessen.de
Study Contact Backup
- Name: Michael John Cekay, MD
- Email: michael.cekay@innere.med.uni-giessen.de
Study Locations
-
-
Hessen
-
Gießen, Hessen, Germany, 35392
- Recruiting
- University Hospital Gießen
-
Contact:
- Michael John Cekay, MD
- Email: michael.cekay@innere.med.uni-giessen.de
-
Contact:
- Bastian Eul, MD
- Email: bastian.eul@innere.med.uni-giessen.de
-
Principal Investigator:
- Khodr Tello, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Equivalent to the average of patients with lung cancer in Germany.
Description
Inclusion Criteria:
- Patient with lung cancer at the University of Giessen lung Cancer Center.
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
All lung cancer patients
There will not be an intervention.
|
There will be no specific interventions.
All patients will receive guidelines based therapy of lung cancer and their comorbidities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary function test measured via Spirometry.
Time Frame: 2 years
|
vital capacity, total lung capacity, forced expiratory volume in one second, functional vital capacity, diffusing capacity for carbon monoxide, arterial partial pressure of oxygen; all measured as % of predicted normal values.
|
2 years
|
sPAP values measured via Echocardiography.
Time Frame: 2 years
|
systolic pulmonary artery pressure (sPAP) measured in millimetre of mercury (mmHg).
|
2 years
|
Body mass index.
Time Frame: 2 years
|
weight and height will be combined to report BMI in kg/m^2.
|
2 years
|
Overall Survival and Progression Free Survival measured in days.
Time Frame: 2 years
|
Overall Survival and Progression free survival in days will be determined by Kaplan-Meier Analysis .Measuared in (st) (time from diagnosis to death)
|
2 years
|
Measurements of the pulmonary artery diameter (PA) and ascending aorta (AA) diameter measured via computed tomography scan. PA and AA will be measured in millimeters.
Time Frame: 2 years
|
PA and AA will be combined to report the PA/AA quotient as indicator for pulmonary hypertension in all lung cancer patients.
With a cut off value of ≥ 1 defining pulmonary hypertension.
|
2 years
|
6 Minute Walk Test in meters.
Time Frame: 2 years
|
The 6 minute walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance.
The distance in meters covered over a time of 6 minutes is used as the outcome.
|
2 years
|
Modified Medical Research Council Scale (mMRC).
Time Frame: 2 years
|
Scores on the mMRC reach from 0-4, with higher scores indicating greater dyspnea.
|
2 years
|
chronic obstructive pulmonary disease assessment test (CAT).
Time Frame: 2 years
|
Scores on the CAT reach from 0-40, with higher scores indicating greater dyspnea.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bastian Eul, MD, JLU Giessen
- Principal Investigator: Khodr Tello, MD, JLU Giessen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2020
Primary Completion (Estimated)
January 29, 2026
Study Completion (Estimated)
January 29, 2040
Study Registration Dates
First Submitted
July 1, 2020
First Submitted That Met QC Criteria
July 8, 2020
First Posted (Actual)
July 13, 2020
Study Record Updates
Last Update Posted (Estimated)
December 5, 2023
Last Update Submitted That Met QC Criteria
December 4, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PH in lung cancer registry
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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