- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03368820
Cardiovascular Morbidities and Lung Cancer Treatment: a Prospective Registry
Cardiovascular Morbidities and Lung Cancer Treatment
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 with cardiovascular events that may impact on the therapeutic decision.
The aim of this registry is to determine if and how cardiovascular co-morbidities impact on the physicians' decision for anticancer treatment in lung cancer patients by comparing it to the European Lung Cancer Working Party (ELCWP) guidelines
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Thierry Berghmans, MD, PhD
- Phone Number: 3192 00322541311
- Email: thierry.berghmans@bordet.be
Study Contact Backup
- Name: Anne-Pascale Meert, MD, PhD
- Phone Number: 3192 003225413111
- Email: nathalie.leclercq@bordet.be
Study Locations
-
-
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Brussels, Belgium, 1000
- Recruiting
- Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
-
Contact:
- Thierry Berghmans, MD
- Phone Number: 0032/2/5390496
-
Principal Investigator:
- Thierry Berghmans, MD
-
Charleroi, Belgium
- Recruiting
- Hôpital Saint-Joseph
-
La Louvière, Belgium
- Recruiting
- Chu Tivoli
-
Contact:
- Ingrid CsToth, MD
-
Principal Investigator:
- Ingrid CsToth, MD
-
Mons, Belgium
- Recruiting
- Hopital Ambroise Pare
-
Verviers, Belgium, 4800
- Recruiting
- CH Peltzer-La Tourelle
-
Contact:
- Yves Bonduelle, MD
-
Principal Investigator:
- Yves Bonduelle, MD
-
Yvoir, Belgium, 5530
- Recruiting
- Hôpital Mont-Godinne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment decision adequacy
Time Frame: 1 year
|
Comparison of physician's treatment decision to current ELCWP guidelines
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment decision adequacy according to histology
Time Frame: 1 year
|
Comparison of physician's treatment decision to current ELCWP guidelines separately in small (SCLC) and non-small lung cancer (NSCLC)
|
1 year
|
Response rate
Time Frame: Every 3 cycles for chemotherapy (9 weeks) or 1 month after completion of radiochemotherapy (15 weeks)
|
Response rate in patients with cardiovascular co-morbidities and adapted treatment using (World Health Organisation (WHO) criteria
|
Every 3 cycles for chemotherapy (9 weeks) or 1 month after completion of radiochemotherapy (15 weeks)
|
Overall survival
Time Frame: 1 year
|
Survival will be measured from the day of diagnostic biopsy.
All patients have to be followed until death
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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