Status:

UNKNOWN

Cardiovascular Morbidities and Lung Cancer Treatment: a Prospective Registry

Lead Sponsor:

European Lung Cancer Working Party

Conditions:

Lung Neoplasm

Eligibility:

All Genders

18+ years

Brief Summary

Therapeutic algorithms for lung cancer are mainly based on randomised controlled trials which excluded patients with severe co-morbidities. Smoking, the main risk factor for lung cancer, is associated...

Eligibility Criteria

Inclusion

  • Histological diagnosis of lung cancer, either NSCLC or SCLC patients and carcinoid tumours
  • Untreated lung cancer of any stage and any treatment (including palliative care only).
  • Availability for participating in the detailed follow-up of the protocol.
  • Signed informed consent.
  • Age above 18 years.
  • Presence of at least one co-morbidity:
  • Any active or past cardiac ischemia
  • Reduced left ventricular ejection fraction (\< 50%)
  • Obstructive cardiomyopathy
  • Valvular dysfunction (3 or 4/4; valvular replacement)
  • Arrhythmia (atrial flutter or fibrillation, significant ventricular arrhythmia, 2nd-3rd degree auriculo-ventricular block, Wolf-Parkinson-White and other similar aberrant conduction, bifascicular block, arrhythmogenic right ventricular dysplasia)
  • Uncontrolled hypertension (systolic blood pressure (BP) \> 160 millimeter of mercury (mmHg) or diastolic BP \> 100 mmHg on ≥ 1 hypotensive drug) or controlled hypertension on ≥ 2 concurrent hypotensive drugs
  • Active or treated peripheral arteritis (grade 2 or more)
  • Cerebrovascular events
  • Pulmonary embolism and/or thrombophlebitis or patients at high risk of thrombophilia (homozygous Leiden factor…)
  • Aortic aneurism

Exclusion

  • Thymoma and thymic malignancies, pleural mesothelioma.
  • Patient previously treated for lung cancer.
  • Tumours for which complete staging cannot be assessed.
  • History of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval).

Key Trial Info

Start Date :

December 4 2017

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2023

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT03368820

Start Date

December 4 2017

End Date

December 31 2023

Last Update

August 23 2021

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, Belgium, 1000

2

Hôpital Saint-Joseph

Charleroi, Belgium

3

CHU Tivoli

La Louvière, Belgium

4

Hôpital Ambroise Paré

Mons, Belgium