Clinical trial · Observational
Tumor Heterogeneity in Diffuse Large B-cell Lymphoma in Relation to CNS Involvement and Cell-free DNA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the project is to clarify whether DLBCL exhibits mutational diversity among different lymph node tumors in one and the same patient. It is desired to find out whether a possible difference between lymph node tumors / tumors can explain why patients who initially (at diagnosis) have the same prognosis, sometimes have a completely different course, eg with rapid recurrence of the disease after treatment. A possible difference could also perhaps shed light on why disease in specific places spreads more frequently to the brain - and therefore have an impact on when one chooses to give preventive treatment against spread to the brain. Monitoring of circulating cell-free DNA (ctDNA) is a new, potential, non-invasive tool for measuring the full spectrum of genetic variations / mutations and is to be investigated in our study as a possible non-invasive assessment of diversity / heterogeneity.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Large B-Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Identify the pattern and variations of mutations in different lymphoma sites in individual patients
- timeFrame
- Through study completion, an average of 1. year
- description
- Differences in mutations will be analyzed with next generation sequencing
Secondary outcomes (6)
- measure
- Identify inter-tumor heterogeneity between nodal and extra-nodal sites
- timeFrame
- 1 year
- description
- Differences in mutations will be analyzed with next generation sequencing
- measure
- Number of patients, with detected heterogeneity, who develop CNS disease, assessed over time
- timeFrame
- 1 year
- description
- The results of next generation sequencing combined with development of CNS disease.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosed with DLBCL 2. Immunochemotherapy (rituximab and CHOP-like chemotherapy) planned and not yet initiated (pretreatment with prednisolone is allowed) 3. Age ≥ 18 years 4. More than 1 lymphoma site accessible for biopsy 5. Patient must consent to permit genetic analysis of their tumor biopsies 6. Patient must consent to additional biopsies and blood samples 7. Tumor biopsy and/or bone-marrow biopsy used for diagnosis available 8. Patient must consent to access of their medical records to monitor the clinical process 9. Written informed consent 10. Baseline 18FDG-PET/CT available Exclusion Criteria: 1. History of previous or current malignancies 2. Other previous/current hematological malignancies or inflammatory disease 3. HIV 4. Concurrent diagnosis of follicular lymphoma or other indolent lymphomas (composite histology) 5. If the patient is deemed to have an acute treatment need, the patient cannot be included in the project. 6. Patients on blood thinners, which must be paused before an additional biopsy, causing too much delay in initiating treatment will be excluded \-
References
Publications (0)
Data not yet available