Cardiotoxicity and other Late effects After Radiotherapy and ImmunochemoTherapy in Non-Hodgkin lYmphoma

Recruiting

Conditions: Non-Hodgkin lymhoma
Lymphatic cancer
10025320
10019280
10003216

Registration Number: NL-OMON55490

Lead Sponsor: ederlands Kanker Instituut

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 525

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: The main study parameters will be symptoms of<br /><br>CVD, biomarkers, echocardiographic systolic and diastolic heart parameters and<br /><br>global longitudinal strain measurement, electrocardiography, arterial stiffness<br /><br>(by pulse wave velocity measurements), endothelial function (by peripheral<br /><br>arterial tonometry), advanced glycation end products will be assessed by skin<br /><br>autofluorescence (AGE-reader). Late effects and risk factors will be assessed<br /><br>through questionnaires and physical measurements. Exposure to (R-)CHOP and<br /><br>radiotherapy will be extracted from the medical history. Multivariable logistic<br /><br>and linear regression analyses will be used for analyses.</p><br>

Secondary Outcome Measures