Development of blood-based monitoring techniques for treatment response evaluation and diagnostics in lymphoid neoplasms, including HL and NHL by using extracellular vesicle and cfDNA techniques for biomarker discovery, assay development and…
ID
Source
Brief title
Condition
- Other condition
- Lymphomas non-Hodgkin's B-cell
- Lymphomas Hodgkin's disease
Synonym
Health condition
Lymphoide maligniteiten volgens WHO 2016 classificatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the development of validated blood-based assays for
monitoring disease status in patients with lymphoid neoplasms and correlation
of blood-based assays with PET response during and after treatment.
Secondary outcome
not applicable
Background summary
The aim of this current study is to develop blood-based monitoring techniques
in malignant lymphoma*s. Positron emission tomography (PET) imaging can be
used by clinicians to detect increased metabolic activity in tissues and
masses. PET is used for evaluation of the extent of the disease and treatment
response in non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). Although PET
imaging in general has a high negative predictive value, the downside of PET
imaging is a relatively poor positive predictive value and increased radiation
burden from repeated scanning for disease monitoring. Hence, there is a
clinical need for blood-based monitoring techniques that can be frequently
repeated to monitor treatment response and help facilitate personalized
treatment per patient. Therefore, blood based methods for monitoring of tumor
activity are under development. In a previous study, we were able to detect and
quantify genetic disease markers (miRNAs) and protein (TARC) in patient plasma,
which levels corresponded with the presence of vital tumor in HL. Hence this
method may be an alternative for, or complement to the current PET imaging for
monitoring treatment response in lymphoma. Circulating cell free tumor DNA
(cfDNA) is another alternative method and is being explored as a
companion-diagnostic or treatment monitoring tool for multiple types of solid
tumors but may also serve as an alternative method for treatment monitoring.
Study objective
Development of blood-based monitoring techniques for treatment response
evaluation and diagnostics in lymphoid neoplasms, including HL and NHL by using
extracellular vesicle and cfDNA techniques for biomarker discovery, assay
development and prospective validation.
Study design
Longitudinal observational COHORT study
Study burden and risks
Patients with lymphoid neoplasms will have no direct benefit from participating
in this study. The additional burden for participating patients consists of
submitting extra blood samples during regular, planned sampling for diagnostic
purposes during and after treatment and during follow-up. The patients will be
not be subjected to extra visits or extra blood draws outside the planned blood
examinations in regular care, thereby not inferring extra risk or additional
burden. In patients who undergo a spinal tap for routine diagnostic or
monitoring purposes as part of regular care, will be invited to submit an extra
tube of CSF (maximum 5 ml) as well for comparison to blood based protocols.
This will also not benefit the patients personally but will provide highly
valuable information for assay development in selected patient groups.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Diagnosed with a lymphoid malignancy as defined in the WHO classification 2016.
Exclusion criteria
Patient is at inclusion also diagnosed with a solid-malignancy, such as breast cancer, colon carcinoma, melanoma or other solid malignancies that requires 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 | NL60245.029.17 |