The primary objective of the study is to qualify an objective semi-quantitative CT scoring system lookingat the correlation between the relative change in the semi-quantitative CT score from baseline to week 6after DIILD diagnosis and the relative…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Relative change of FVC between study entry (DIILD diagnosis) and 6 weeks after
diagnosis (treatment adaptation)
- Relative change in the semi-quantitative radiology scores between study entry
(DIILD diagnosis) and 6 weeks after diagnosed DIILD (treatment adaptation)
Secondary outcome
To be evaluated at study entry, at 6 weeks and 6 months:
* FVC
* Other pulmonary physiology results (e.g. DLCO and 6MWT)
* Respiratory patient report outcome
* Quality of life
To be evaluated at study entry and at 6 weeks:
* Radiology qualitative analysis (3 grading)
* Quantitative volumetric inspiratory CT measurements
Background summary
Drug induced interstitial lung disease (DIILD) is caused by iatrogenic injury
to the lung parenchyma and can be caused by over four hundred different drugs
in humans. The incidence of DIILD in modern oncology practice is unknown but
available evidence suggests that this is underdiagnosed worldwide. The
incidence of DIILD has increased in the past 15 years, and is predicted to
continue to rise with the advent of new generation anti-cancer drugs where the
risk of lung injury is seldom recognized during early drug development.
Clinical manifestations range from mild to severe and progressive. In its more
severe form, DIILD may result in acute respiratory distress syndrome,
respiratory failure and death. Early recognition of DIILD is important because
lung injury can be reversed if appropriate therapy is instituted soon after the
onset of symptoms.
Study objective
The primary objective of the study is to qualify an objective semi-quantitative
CT scoring system looking
at the correlation between the relative change in the semi-quantitative CT
score from baseline to week 6
after DIILD diagnosis and the relative change in FVC from baseline to week 6
after DIILD diagnosis.
Study design
multicenter, multinational
non-randomized, non-drug
patients will be followed for 6 months from diagnosis of DIILD, data will be
collected, patients will undergo questionnaires, CT's, blood draws, pulmonary
function tests
Study burden and risks
Burden in time is that patients undergo extra assessments, but these are
usually not burdensome for the patients (non-burdensome questionnaires,
CT-chest, pulmonary function tests)
Risk: the questionnaires are non-burdensome, radiation of a chest CT is
neglible nowadays, patient can get dizzy from a pulmonary function test. Blood
draws can cause a hematoma, this can be uncomfortable for the patient.
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Avenue E. Mounier 83/11
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Listed location countries
Age
Inclusion criteria
* Age * 18 years
* WHO performance status 0-2
* Life expectancy > 6 months
* Proven cancer diagnosis in a patient actively undergoing systemic anticancer
therapy
* New onset symptoms (e.g. cough, fever, dyspnoea, and hypoxia) at any
time during or within 4 weeks of the last dose of anti-cancer treatment
* New onset radiological (CXR or CT) abnormalities within the lungs at any
time during or within 4 weeks of the last dose of anti-cancer treatment
(e.g. diffuse lung changes, infiltrative opacification in the periphery of the
lung or ground glass changes) with a locally reviewed diagnosis of DIILD as
the most likely explanation for the radiological abnormalities.
* Treatment for DIILD planned (e.g. drug withdrawal, interruption +/-
supportive therapy including corticosteroids, oxygen, bronchodilators etc.).
Treatment with antibiotics, anticoagulants etc. is permitted pending results
of investigations for differential diagnoses.
* Able to undergo pulmonary function tests (at a minimum spirometry and
gas transfer (DLCO))
* Patients enrolled on other anti-cancer investigational trials are permitted
at investigator discretion
* Informed written consent obtained according to ICH/GCP, and
national/local regulations
* Women of child bearing potential (WOCBP) must have a negative serum (or
urine) pregnancy test within 14 days before study registration
Exclusion criteria
* Primary lung tumor greater than 3cm
* Lung metastatic lesion > 2cm or greater than 5 metastases
* Claustrophobia, or inability to undergo non-contrast CT examination
* Known or suspected non-drug related ILD (e.g. lung abnormalities due to
other causes such as occupational exposure)
* Previous thoracic lobectomy
* Clinical, radiological or microbiological evidence of active lower respiratory
tract infection
* Currently active, clinically significant heart disease, such as uncontrolled
class 3 or 4 congestive heart failure defined by the New York Heart
Association Functional Classification
* Any medical, psychological, sociological or geographical condition that
could affect participation in the study and compliance with the study
protocol
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnumber03294746 |
| CCMO | NL64729.068.18 |