Giessen Pulmonary Hypertension in Lung Cancer Registry

NCT04467333 | Recruiting

• 1 other identifier: PH in lung cancer registry
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hypertension Due to Lung Diseases and Hypoxia

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

All lung cancer patients

There will not be an intervention.

Other: All lung cancer patients.

Interventions

All lung cancer patients. OTHER

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

All lung cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Equivalent to the average of patients with lung cancer in Germany.

You may qualify if:

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

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University hospital Giessen

Giessen, Hesse, 35392, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 29141888 BACKGROUND

• Rako ZA, Cekay M, Yogeswaran A, Yildiz S, Arndt PF, Kremer N, Schafer S, Janetzko P, Thal BR, Mummert CM, Franken JK, Soethe H, Werner HF, Dumitrascu R, Grimminger F, Ghofrani HA, Pullamsetti SS, Seeger W, Naeije R, Savai R, Eul B, Tello K. Echocardiographic Measure of Right Ventricular-Pulmonary Arterial Coupling Predicts Survival in Lung Cancer. Ann Am Thorac Soc. 2025 Jul;22(7):1071-1078. doi: 10.1513/AnnalsATS.202409-949OC.

  PMID: 40042816 DERIVED

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bastian Eul, MD

  JLU Giessen

  PRINCIPAL INVESTIGATOR

• Khodr Tello, MD

  JLU Giessen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bastian Eul, MD

CONTACT

(+49) 0641/985-42371; bastian.eul@innere.med.uni-giessen.de

Michael John Cekay, MD

CONTACT

michael.cekay@innere.med.uni-giessen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 13, 2020
• Study Start: June 29, 2020
• Primary Completion: January 29, 2026
• Study Completion (Estimated): January 29, 2040
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

DE (1)