Giessen Pulmonary Hypertension in Lung Cancer Registry

Pulmonary Hypertension Due to Lung Diseases and Hypoxia Clinical Trial

— PHLHR  

Official title:

Giessen Pulmonary Hypertension in Lung Cancer Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04467333
• Other study ID #: PH in lung cancer registry
• Status: Recruiting
• Start date: June 29, 2020
• Est. completion date: January 29, 2040

Study information

• Verified date: December 2023
• Source: University of Giessen
• Contact: Bastian Eul, MD
• Phone: (+49) 0641/985-42371
• Email: bastian.eul[@]innere.med.uni-giessen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 29, 2040
• Est. primary completion date: January 29, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with lung cancer at the University of Giessen lung Cancer Center.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Hypoxia
• Lung Diseases
• Pulmonary Hypertension Due to Lung Diseases and Hypoxia

Intervention

Other:
• All lung cancer patients.
There will be no specific interventions. All patients will receive guidelines based therapy of lung cancer and their comorbidities.

Locations

Country	Name	City	State
Germany	University hospital Giessen	Gießen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Pullamsetti SS, Kojonazarov B, Storn S, Gall H, Salazar Y, Wolf J, Weigert A, El-Nikhely N, Ghofrani HA, Krombach GA, Fink L, Gattenlohner S, Rapp UR, Schermuly RT, Grimminger F, Seeger W, Savai R. Lung cancer-associated pulmonary hypertension: Role of microenvironmental inflammation based on tumor cell-immune cell cross-talk. Sci Transl Med. 2017 Nov 15;9(416):eaai9048. doi: 10.1126/scitranslmed.aai9048. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary function test measured via Spirometry.	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
Primary	sPAP values measured via Echocardiography.	systolic pulmonary artery pressure (sPAP) measured in millimetre of mercury (mmHg).	2 years
Primary	Body mass index.	weight and height will be combined to report BMI in kg/m^2.	2 years
Primary	Overall Survival and Progression Free Survival measured in days.	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
Primary	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.	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
Primary	6 Minute Walk Test in meters.	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
Primary	Modified Medical Research Council Scale (mMRC).	Scores on the mMRC reach from 0-4, with higher scores indicating greater dyspnea.	2 years
Primary	chronic obstructive pulmonary disease assessment test (CAT).	Scores on the CAT reach from 0-40, with higher scores indicating greater dyspnea.	2 years