Giessen Pulmonary Hypertension in Lung Cancer Registry (PHLHR)

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
• Conditions: Pulmonary Hypertension Due to Lung Diseases and Hypoxia
• Intervention / Treatment: Other: All lung cancer patients.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• 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

• Germany
  • 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

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All lung cancer patients; There will not be an 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
sPAP values measured via Echocardiography.	systolic pulmonary artery pressure (sPAP) measured in millimetre of mercury (mmHg).	2 years
Body mass index.	weight and height will be combined to report BMI in kg/m^2.	2 years
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
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
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
Modified Medical Research Council Scale (mMRC).	Scores on the mMRC reach from 0-4, with higher scores indicating greater dyspnea.	2 years
chronic obstructive pulmonary disease assessment test (CAT).	Scores on the CAT reach from 0-40, with higher scores indicating greater dyspnea.	2 years

Collaborators and Investigators

• Sponsor: University of Giessen
• Investigators: Principal Investigator: Bastian Eul, MD, JLU Giessen; Principal Investigator: Khodr Tello, MD, JLU Giessen

Publications and helpful links

General Publications

• 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.

Study record dates

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 (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Lung Diseases; Hypertension; Hypoxia; Hypertension, Pulmonary
• 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