to assess the pulmonary toxicity in patients treated with cyclophosphamide compared to a control group
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Abnormal PFT, defined as TLC/FVC <75% (restrictive dysfunction) of predicted
for age and sex matched controls of a normal population.
Other PFT parameters, i.e. FEV1%FVC <75% (obstruction) and/or DLCO/TLCO <75%
(diffusion).
Secondary outcome
not applicable
Background summary
Advances in diagnosis and treatment of childhood cancer over the last decades
have dramatically increased long-term survival. As a result, the numbers of
childhood cancer survivors (CCS) are growing and it has become increasingly
clear that the former disease and its treatment can significantly impair
long-term health. The need for long-term follow-up is uniformly recognized.
Research focusing on identification and characterization of high-risk
populations is an essential foundation on which to build evidence-based
recommendations for long-term follow-up. Furthermore, research focusing on more
accurate screening tests and effective interventions is needed to reduce excess
morbidity and mortality in CCS. The SKION LATER Q2008 - pulmonology study
phocuses on late pulmonary toxicity in CCS
Study objective
to assess the pulmonary toxicity in patients treated with cyclophosphamide
compared to a control group
Study design
In 2 groups of childhood cancer survivors (CCS, each 260 patients) pulmonary
late effects will be assessed by a pulmonary function test:
- CCS treated with cyclophosphamide but no other potentially pulmotoxic
treatment modalities (chemo and/or radiotherapy)
- CCS treated with neither cyclophosphamide nor any other potentially
pulmotoxic treatment modalities (chemo and/or radiotherapy)
Study burden and risks
no risks associated with the pulmonary function test. The test is not painful,
patients wil have to blow in a tube
Heidelberglaan 25
Utrecht 3584CS
NL
Heidelberglaan 25
Utrecht 3584CS
NL
Listed location countries
Age
Inclusion criteria
childhood cancer survivors (CCS) who either received cyclophosphamide (Cy)
treatment but no other potentially pulmotoxic treatment or who received neither
Cy nor any other potentially pulmotoxic treatment
Exclusion criteria
childhood cancer survivors who received potentially pulmotoxic treatment
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 |
|---|---|
| CCMO | NL35002.018.11 |