NCT03368820

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

December 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 23, 2021

Status Verified

August 1, 2021

Enrollment Period

5.1 years

First QC Date

November 24, 2017

Last Update Submit

August 20, 2021

Conditions

Lung Neoplasm

Keywords

lung neoplasmscardiovascular co-morbidity

Outcome Measures

Primary Outcomes (1)

  • Treatment decision adequacy

    Comparison of physician's treatment decision to current ELCWP guidelines

    1 year

Secondary Outcomes (3)

  • Treatment decision adequacy according to histology

    1 year

  • Response rate

    Every 3 cycles for chemotherapy (9 weeks) or 1 month after completion of radiochemotherapy (15 weeks)

  • Overall survival

    1 year

Interventions

No interventionOTHER

Treatment left at the discretion of the participant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any untreated lung cancer whatever the treatment intent

You may qualify if:

  • 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…)
  • +1 more criteria

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, 1000, Belgium

RECRUITING

Hôpital Saint-Joseph

Charleroi, Belgium

RECRUITING

CHU Tivoli

La Louvière, Belgium

RECRUITING

Hôpital Ambroise Paré

Mons, Belgium

RECRUITING

CH Peltzer-La Tourelle

Verviers, 4800, Belgium

RECRUITING

Hôpital Mont-Godinne

Yvoir, 5530, Belgium

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Thierry Berghmans, MD, PhD

    ELCWP

    STUDY CHAIR

Central Study Contacts

Thierry Berghmans, MD, PhD

CONTACT

00322541311thierry.berghmans@bordet.be

Anne-Pascale Meert, MD, PhD

CONTACT

003225413111nathalie.leclercq@bordet.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2017

First Posted

December 11, 2017

Study Start

December 4, 2017

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

August 23, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(6)