Pulmonary Hypertension Due to Lung Diseases and HypoxiaPHLHRNCT04467333
Giessen Pulmonary Hypertension in Lung Cancer Registry
An observational study of Pulmonary Hypertension Due to Lung Diseases and Hypoxia, run by University of Giessen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension Due to Lung Diseases and Hypoxia
- What is being tested?
- All lung cancer patients.
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jun 2020to 29 Jan 2040
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Equivalent to the average of patients with lung cancer in Germany.
Who may be able to join
- Patient with lung cancer at the University of Giessen lung Cancer Center.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael John Cekay, MD contact
Germany1 site, 1 recruiting
- Recruiting
University hospital Giessen
Giessen, Hesse, 35392
Bastian Eul, MD, bastian.eul@innere.med.uni-giessen.de
Michael John Cekay, MD, michael.cekay@innere.med.uni-giessen.de
About this study
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.
- Being tested
- All lung cancer patients.
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All lung cancer patients.Other
There will be no specific interventions. All patients will receive guidelines based therapy of lung cancer and their comorbidities.
| Study group | Role | What they receive |
|---|---|---|
| All lung cancer patients | There will not be an intervention. Receives: Other: All lung cancer patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
sPAP values measured via Echocardiography.
systolic pulmonary artery pressure (sPAP) measured in millimetre of mercury (mmHg).
Measured: 2 years
Body mass index.
weight and height will be combined to report BMI in kg/m^2.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 2 years
Modified Medical Research Council Scale (mMRC).
Scores on the mMRC reach from 0-4, with higher scores indicating greater dyspnea.
Measured: 2 years
chronic obstructive pulmonary disease assessment test (CAT).
Scores on the CAT reach from 0-40, with higher scores indicating greater dyspnea.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start29 Jun 2020
- Primary completion29 Jan 2026 (estimated)
- Study completion29 Jan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Hypertension Due to Lung Diseases and HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bastian Eul, MD, Principal investigator, JLU GiessenKhodr Tello, MD, Principal investigator, JLU Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467333
- Sponsor's protocol ID
- PH in lung cancer registry
- Acronym
- PHLHR
- Status last verified
- Mar 2025
- First submitted
- 1 Jul 2020
- Last updated
- 1 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 29141888Rako 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.
PubMed 40042816
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giessen Pulmonary Hypertension in Lung Cancer Registry
- ClinicalTrials.gov ID
- NCT04467333
- Acronym / sponsor ID
- PHLHR / PH in lung cancer registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 29 Jan 2026 (estimated)
- Study completion
- 29 Jan 2040 (estimated)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All lung cancer patients | – | Other: All lung cancer patients.There will not be an intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Equivalent to the average of patients with lung cancer in Germany.
Key inclusion criteria (1 listed)
- Patient with lung cancer at the University of Giessen lung Cancer Center.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All lung cancer patients.There will be no specific interventions. All patients will receive guidelines based therapy of lung cancer and their comorbidities. | Other | All lung cancer patients |
Primary outcome
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.
sPAP values measured via Echocardiography.
Time frame: 2 years
systolic pulmonary artery pressure (sPAP) measured in millimetre of mercury (mmHg).
Body mass index.
Time frame: 2 years
weight and height will be combined to report BMI in kg/m^2.
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)
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 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.
Modified Medical Research Council Scale (mMRC).
Time frame: 2 years
Scores on the mMRC reach from 0-4, with higher scores indicating greater dyspnea.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Background: PubMed 29141888Pullamsetti 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.
- Derived from this study: PubMed 40042816Rako 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael John Cekay, MD contact
Bastian Eul, MD principal investigator
JLU Giessen
Khodr Tello, MD principal investigator
JLU Giessen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension Due to Lung Diseases and Hypoxia, run by University of Giessen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bastian Eul, MD ((+49) 0641/985-42371, bastian.eul@innere.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function test measured via Spirometry. (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04467333, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.