Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cardiovascular Morbidities and Lung Cancer Treatment: a Prospective Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03368820
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : August 23, 2021
Sponsor:
Information provided by (Responsible Party):
European Lung Cancer Working Party

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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


Condition or disease Intervention/treatment
Lung Neoplasm Other: No intervention

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Cardiovascular Morbidities and Lung Cancer Treatment
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: No intervention
    Treatment left at the discretion of the participant

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Treatment decision adequacy [ Time Frame: 1 year ]
    Comparison of physician's treatment decision to current ELCWP guidelines


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. Overall survival [ Time Frame: 1 year ]
    Survival will be measured from the day of diagnostic biopsy. All patients have to be followed until death


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any untreated lung cancer whatever the treatment intent
Criteria

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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368820


Contacts
Layout table for location contacts
Contact: Thierry Berghmans, MD, PhD 00322541311 ext 3192 thierry.berghmans@bordet.be
Contact: Anne-Pascale Meert, MD, PhD 003225413111 ext 3192 nathalie.leclercq@bordet.be

Locations
Layout table for location information
Belgium
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Thierry Berghmans, MD    0032/2/5390496      
Principal Investigator: Thierry Berghmans, MD         
Hôpital Saint-Joseph Recruiting
Charleroi, Belgium
Contact: Benoit Colinet, MD         
Principal Investigator: Benoit Colinet, MD         
CHU Tivoli Recruiting
La Louvière, Belgium
Contact: Ingrid CsToth, MD         
Principal Investigator: Ingrid CsToth, MD         
Hôpital Ambroise Paré Recruiting
Mons, Belgium
Contact: Stéphane Holbrechts, MD         
Principal Investigator: Stéphane Holbrechts, MD         
CH Peltzer-La Tourelle Recruiting
Verviers, Belgium, 4800
Contact: Yves Bonduelle, MD         
Principal Investigator: Yves Bonduelle, MD         
Hôpital Mont-Godinne Recruiting
Yvoir, Belgium, 5530
Contact: Sebahat Ocak, MD, PhD         
Principal Investigator: Sebahat Ocak, MD, PhD         
Sponsors and Collaborators
European Lung Cancer Working Party
Investigators
Layout table for investigator information
Study Chair: Thierry Berghmans, MD, PhD ELCWP
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: European Lung Cancer Working Party
ClinicalTrials.gov Identifier: NCT03368820    
Other Study ID Numbers: 01151
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by European Lung Cancer Working Party:
lung neoplasms
cardiovascular co-morbidity
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases