PHLHR: Giessen Pulmonary Hypertension in Lung Cancer Registry

• Sponsor: University of Giessen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04467333
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 235
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension Due to Lung Diseases and Hypoxia	Other: All lung cancer patients.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Giessen Pulmonary Hypertension in Lung Cancer Registry
• Actual Study Start Date: Jun 29, 2020
• Anticipated Primary Completion Date: Jan 29, 2024
• Anticipated Study Completion Date: Jan 29, 2040

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Pulmonary function test measured via Spirometry. [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. [2 years]

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

3. Body mass index. [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. [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. [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. [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). [2 years]

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

8. chronic obstructive pulmonary disease assessment test (CAT). [2 years]

   Scores on the CAT reach from 0-40, with higher scores indicating greater dyspnea.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University hospital Giessen	Gießen	Hessen	Germany	35392

Sponsors and Collaborators

• University of Giessen

Investigators

• Principal Investigator: Bastian Eul, MD, JLU Giessen
• Principal Investigator: Khodr Tello, MD, JLU Giessen

Study Documents (Full-Text)

None provided.

More Information

Publications

• Pullamsetti SS, Kojonazarov B, Storn S, Gall H, Salazar Y, Wolf J, Weigert A, El-Nikhely N, Ghofrani HA, Krombach GA, Fink L, Gattenlöhner 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). pii: eaai9048. doi: 10.1126/scitranslmed.aai9048.

• Responsible Party: University of Giessen
• ClinicalTrials.gov Identifier: NCT04467333
• Other Study ID Numbers: PH in lung cancer registry
• First Posted: Jul 13, 2020
• Last Update Posted: Nov 18, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Diseases; Hypertension, Pulmonary; Hypertension; Hypoxia

Study Results

No Results Posted as of Nov 18, 2021