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NCT Number: NCT04467333

Giessen Pulmonary Hypertension in Lung Cancer Registry

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.

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Key information

Conditions

Pulmonary Hypertension Due to Lung Diseases and Hypoxia Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital Giessen

Giessen, Hesse, 35392, Germany

Location status: Recruiting

Location contact

Bastian Eul, MD

CONTACT

[email protected]

Khodr Tello, MD

PRINCIPAL_INVESTIGATOR

Michael John Cekay, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

All lung cancer patients.

Other

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

Primary outcomes

  1. 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. sPAP values measured via Echocardiography.

    Time frame: 2 years

    systolic pulmonary artery pressure (sPAP) measured in millimetre of mercury (mmHg).

  3. Body mass index.

    Time frame: 2 years

    weight and height will be combined to report BMI in kg/m^2.

  4. 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)

  5. 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.

  6. 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.

  7. Modified Medical Research Council Scale (mMRC).

    Time frame: 2 years

    Scores on the mMRC reach from 0-4, with higher scores indicating greater dyspnea.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bastian Eul, MD

CONTACT

[email protected]

(+49) 0641/985-42371

Michael John Cekay, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Acronym: PHLHR

Important dates

Study start
2020
Primary completion
2026
Study completion
2040
First posted
Jul 13, 2020
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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