Objective: Our main objective is to assess in detail risk factors for cardiovascular disease and cardiotoxicity and to compare heart function parameters, vascular parameters and biomarkers associated with cardiovascular function among 5- to 18-year…
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's B-cell
- Heart failures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The main study parameters will be symptoms of
CVD, biomarkers, echocardiographic systolic and diastolic heart parameters and
global longitudinal strain measurement, electrocardiography, arterial stiffness
(by pulse wave velocity measurements), endothelial function (by peripheral
arterial tonometry), advanced glycation end products will be assessed by skin
autofluorescence (AGE-reader). Late effects and risk factors will be assessed
through questionnaires and physical measurements. Exposure to (R-)CHOP and
radiotherapy will be extracted from the medical history. Multivariable logistic
and linear regression analyses will be used for analyses.
Secondary outcome
.
Background summary
Rationale: Few studies have thus far addressed the burden from
treatment-related cardiovascular disease in long-term survivors of
non-Hodgkin*s lymphoma (NHL). The life expectancy of patients with aggressive
B-cell NHL has significantly increased since treatment regimens have improved.
Although the addition of rituximab to CHOP chemotherapy does not appear to
increase cardiotoxicity during treatment, little is known about the long-term
cardiac safety of R-CHOP. Nonetheless, cardiotoxicity due to doxorubicin
exposure appears to be a key problem in clinical practice, while radiation
exposure of the heart may add to cardiac disease risk.
Study objective
Objective: Our main objective is to assess in detail risk factors for
cardiovascular disease and cardiotoxicity and to compare heart function
parameters, vascular parameters and biomarkers associated with cardiovascular
function among 5- to 18-year survivors, treated for aggressive B-cell NHL, and
sibling controls. Secondary objectives are to assess the prevalence of other
late effects (quality of life, metabolic syndrome), the effects of individual
immune- and chemotherapeutic agents and radiation exposure and the predictive
value of newly developed markers for CVD.
Study design
Study design: We will evaluate these parameters in a cross-sectional study,
nested in a well characterized cohort of DLBCL survivors.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: With the results of our study, guidelines for
follow up and prevention will be developed which will benefit the participants
during their own follow up in the future. The burden of participating is
expected to be low since the study is observational and we combine assessments
required in the context of research as much as possible with the provided
standard of care for survivors during one or two hospital visits.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet the
following criteria.
Survivors:
• 350 survivors of mediastinal large B-cell non-Hodgkin lymphoma (ICD-code
9679) or diffuse large B-cell non-Hodgkin lymphoma (ICD-code 9684), treated
with at least five cycles of (R-)CHOP (250 mg/m2 anthracyclines or more) or
treated with a combination of mediastinal radiotherapy and anthracyclines
(independent of dose).
o 200 survivors treated between five to thirteen years ago (2007-2015)
o 150 survivors treated between thirteen to eighteen years ago (2002-2007)
• The survivors were treated in one of the following centers, participating in
the BETER-consortium: Amsterdam UMC (location VUmc or AMC), EMC, UMCU, UMCG,
UMC Radboud or ASZ.
• Age at diagnosis 15 up to 60 years.
• Age at the time of inclusion: younger than 75 years old., Comparison group:
• 175 siblings of the above mentioned patients with their date of birth closest
to the birthdate of the survivor.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Use of immunosuppressant and/or prednisolone
• HIV-infected individuals
• Pregnant women
• Mental disability or psychological condition potentially hampering compliance
with the study protocol
• Insufficient understanding of the Dutch language
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 | NL66682.031.18 |
| Other | The NCT number (clinicaltrials.gov) will follow |