NCT07041827

Brief Summary

Survivors of non-Hodgkin lymphoma and a control group will be screened for (sub)clinical cardiovascular disease, to assess the influence of contemporary treatments on risk and burden of (sub)clinical cardiovascular disease and their influence on survival.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
217

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

2.7 years

First QC Date

February 20, 2019

Last Update Submit

June 19, 2025

Conditions

Non Hodgkin LymphomaDLBCLCardiovascular DiseasesCardiomyopathiesCardiotoxicityMetabolic SyndromeQuality of LifeLate EffectHeart Failure

Keywords

CardiotoxicityNon-Hodgkin lymphomaLate effectsSurvivor

Outcome Measures

Primary Outcomes (1)

  • Echocardiography: systolic and diastolic heart parameters, various strain measurements such as global longitudinal strain

    LVEF (continuous), LVEF\<50%, GLS (continuous) GLS\>-18%, NT-proBNP (continuous), NT-proBNP\>=125 pg/mL

    Once, at enrollment

Secondary Outcomes (7)

  • Electrocardiography

    Once, at enrollment

  • Pulse wave velocity

    Once, at enrollment

  • Association of different biomarkers

    Once, at enrollment

  • EndoPAT (peripheral arterial tonometry)

    Once, at enrollment

  • Metabolic syndrome

    Once, at enrollment

  • +2 more secondary outcomes

Study Arms (2)

Survivors

Over the past years, a Dutch multicentre hospital-based patient cohort of 5-year non-Hodgkin lymphoma survivors has been established. Survivors will be invited for the current study by their treating physician through the BETER survivorship clinics, or when patients have been dismissed from clinical follow-up, by their former treating physician (or head of the medical department, if the treating physician is retired) within each BETER clinic.

Diagnostic Test: Cardiovascular assessment

Siblings

As there are no patients who are unexposed to potential cardiotoxic treatment in the BETER cohort we will request every participating NHL survivor to approach one of their siblings, more specifically the sibling who is closest in birthdate to the birthdate of the survivor, for participation in the study.

Diagnostic Test: Cardiovascular assessment

Interventions

Cardiovascular assessmentDIAGNOSTIC_TEST

A cardiovascular assessment will be performed to screen for (sub)clinical cardiovascular diseases and to compare the prevalences in survivors of non-Hodgkin lymphoma and a control group.

Also known as: Blood & urine sampling (biomarkers), Echocardiography, Electrocardiography, Pulse wave velocity (arterial stiffness), EndoPAT (peripheral arterial tonometry - endothelial dysfunction), AGE-reader (advanced glycation end products), Questionnaires (cardiovascular risk factors & quality of life)
SiblingsSurvivors

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Survivors: Over the past years, a Dutch multicentre hospital-based patient cohort of 5-year non-Hodgkin lymphoma survivors has been established. Survivors will be invited for the current study by their treating physician through the BETER survivorship clinics, or when patients have been dismissed from clinical follow-up, by their former treating physician (or head of the medical department, if the treating physician is retired) within each BETER clinic. * Siblings: As there are no patients who are unexposed to potential cardiotoxic treatment in the BETER cohort we will request every participating NHL survivor to approach one of their siblings, more specifically the sibling who is closest in birthdate to the birthdate of the survivor, for participation in the study.

You may qualify if:

  • year survivors from the patient cohort with (mediastinal) large B-cell non-Hodgkin lymphoma (ICD-code 9679) or diffuse large B-cell non-Hodgkin lymphoma (ICD-code 9684), treated with R-CHOP:
  • survivors treated between five to ten years ago (2007-2012)
  • survivors treated between ten to fifteen years ago (2002-2007)
  • Treated in one of the following centers: AVL, Amsterdam UMC (location VUmc or AMC), LUMC, EMC, UMCU, UMCG, UMC Radboud.
  • Age at diagnosis 15 up to 60 years.

You may not qualify if:

  • 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
  • siblings of the above mentioned patients (maximum of 1 sibling per patient) with their date of birth closest to the birthdate of the survivor.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

EDTA-plasma, serum, EDTA-whole blood (for DNA), citrate, heparin

MeSH Terms

Conditions

Lymphoma, Non-HodgkinCardiovascular DiseasesCardiomyopathiesCardiotoxicityMetabolic SyndromeHeart Failure

Interventions

Blood Specimen CollectionEchocardiographyElectrocardiographyPulse Wave AnalysisVascular Stiffness

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and InjuriesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesCardiac Imaging TechniquesDiagnostic ImagingUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularElectrodiagnosisCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Michael Schaapveld, PhD

    The Netherlands Cancer Institute

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2019

First Posted

June 27, 2025

Study Start

February 1, 2020

Primary Completion

October 1, 2022

Study Completion

February 1, 2023

Last Updated

June 27, 2025

Record last verified: 2025-06

Locations

NL(1)