Lung NeoplasmNCT03368820
Cardiovascular Morbidities and Lung Cancer Treatment: a Prospective Registry
An observational study of Lung Neoplasm, run by European Lung Cancer Working Party at 6 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm
- How many people
- 200 participants
- Where
- 6 sitesBelgium
- Study dates
- 4 Dec 2017to 31 Dec 2023
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Any untreated lung cancer whatever the treatment intent
Who may be able to join
- 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:
Show all 16Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites, 6 recruiting
- Recruiting
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, 1000
Thierry Berghmans, MD, 0032/2/5390496
Thierry Berghmans, MD
- Recruiting
Hôpital Saint-Joseph
Charleroi
Benoit Colinet, MD
Benoit Colinet, MD
- Recruiting
CHU Tivoli
La Louvière
Ingrid CsToth, MD
Ingrid CsToth, MD
- Recruiting
Hôpital Ambroise Paré
Mons
Stéphane Holbrechts, MD
Stéphane Holbrechts, MD
- Recruiting
CH Peltzer-La Tourelle
Verviers, 4800
Yves Bonduelle, MD
Yves Bonduelle, MD
- Recruiting
Hôpital Mont-Godinne
Yvoir, 5530
Sebahat Ocak, MD, PhD
Sebahat Ocak, MD, PhD
About this study
Official title: 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
- Conditions
- Lung Neoplasm
- Being tested
- No intervention
- Keywords
- lung neoplasms, cardiovascular co-morbidity
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Treatment left at the discretion of the participant
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment decision adequacy
Comparison of physician's treatment decision to current ELCWP guidelines
Measured: 1 year
Secondary outcomes (3)
Treatment decision adequacy according to histology
Comparison of physician's treatment decision to current ELCWP guidelines separately in small (SCLC) and non-small lung cancer (NSCLC)
Measured: 1 year
Response rate
Response rate in patients with cardiovascular co-morbidities and adapted treatment using (World Health Organisation (WHO) criteria
Measured: Every 3 cycles for chemotherapy (9 weeks) or 1 month after completion of radiochemotherapy (15 weeks)
Overall survival
Survival will be measured from the day of diagnostic biopsy. All patients have to be followed until death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start4 Dec 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies 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
- 200 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- European Lung Cancer Working Party
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Berghmans, MD, PhD, Study chair, ELCWP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368820
- Sponsor's protocol ID
- 01151
- Status last verified
- Aug 2021
- First submitted
- 24 Nov 2017
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Morbidities and Lung Cancer Treatment
- ClinicalTrials.gov ID
- NCT03368820
- Acronym / sponsor ID
- 01151
- Conditions
- Lung Neoplasm
- Keywords
- lung neoplasms, cardiovascular co-morbidity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- European Lung Cancer Working PartyUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Dec 2017 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any untreated lung cancer whatever the treatment intent
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| No interventionTreatment left at the discretion of the participant | Other | – |
Primary outcome
Treatment decision adequacy
Time frame: 1 year
Comparison of physician's treatment decision to current ELCWP guidelines
3 secondary outcomes
Treatment decision adequacy according to histology
Time frame: 1 year
Response rate
Time frame: Every 3 cycles for chemotherapy (9 weeks) or 1 month after completion of radiochemotherapy (15 weeks)
Overall survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Thierry Berghmans, MD, PhD study chair
ELCWP
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Neoplasm, run by European Lung Cancer Working Party at 6 sites in Belgium.
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 16 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thierry Berghmans, MD, PhD (00322541311 ext. 3192, thierry.berghmans@bordet.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment decision adequacy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2021.