Role of genomic factors on late adverse events after lymphoma

Role of genomic factors on late adverse events after lymphoma - BETER-REFLECTIE study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52606

Enrollment

5000

Registered

2020-08-21

Start date

2021-03-31

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin lymphoma

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - 5-years survivors of Hodgkin lymphoma (HL) or diffuse large B-cell non-Hodgkin lymphoma (DLBCL) - Age at HL/DLBCL diagnosis between 15 and 60 years - Treated at one of the participating BETER centers - Living survivors: written informed consent

Exclusion criteria

Exclusion criteria: we will exclude survivors who have previously indicated at the BETER clinic that they do not want to be approached for (further) research (less than 2% of the BETER population).

Design outcomes

Primary

Measure	Time frame
The main study endpoints are the occurrence of clinically diagnosed second malignant neoplasms (SMNs) and cardiovascular disease CVD) at least 5 years after treatment for lymphoma. We will the association of genomic markers with the risk of SMNs and/or CVD in 5-year survivors of HL or DLBCL.	—

Secondary

Measure	Time frame
As secondary study endpoints we will assess the occurrence of other late adverse events and (intermediate) parameters of treatment-associated toxicity. These include the metabolic syndrome and health-related quality of life measures. We will also assess the functional impact of identified genomic markers on relevant gene and protein expression levels. In an optional part of the study, we will assess the molecular profile of treatment-associated second malignancies.	—

Measure

Time frame

As secondary study endpoints we will assess the occurrence of other late adverse events and (intermediate) parameters of treatment-associated toxicity. These include the metabolic syndrome and health-related quality of life measures. We will also assess the functional impact of identified genomic markers on relevant gene and protein expression levels. In an optional part of the study, we will assess the molecular profile of treatment-associated second malignancies.

—

Countries

Netherlands

Outcome results