Cardiovascular Morbidities and Lung Cancer Treatment: a P... | NCT03368820

Studies
Cardiovascular Morbidities and Lung Cancer Treatment: a Prospective Registry

NCT03368820

Sponsor

European Lung Cancer Working Party

Status

Unknown status

Last Update Posted

Aug 23, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Lung Neoplasm

Interventions

No intervention

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 4, 2017Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Nov 24, 2017

First Submission Date that Met QC Criteria

Dec 8, 2017

First Posted Date

Dec 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2021

Last Update Posted Date

Aug 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	Treatment left at the discretion of the participant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment decision adequacy	Comparison of physician's treatment decision to current ELCWP guidelines	1 year

Secondary Outcomes

Measure	Description	Time Frame
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)	1 year
Response rate

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Any untreated lung cancer whatever the treatment intent

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thierry Berghmans, MD, PhD	Contact	00322541311	3192	thierry.berghmans@bordet.be
Anne-Pascale Meert, MD, PhD	Contact	003225413111	3192	nathalie.leclercq@bordet.be

Overall Officials

Name	Affiliation	Role
Thierry Berghmans, MD, PhD	ELCWP	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet	Recruiting	Brussels		1000	Belgium

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms