Clinical trial · Observational
Enhancing Diagnosis in Chronic B-cell Lymphoproliferative Disorders Using Next-Generation Sequencing
ENABLE-NGS: Enhancing Diagnosis in Chronic B-cell Lymphoproliferative Disorders Using Next-Generation Sequencing
NCT03344809CI-TRIAL-00076342ENABLE-NGSunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
To enhance the diagnosis of unclassifiable, non-CLL B-LPDs using next-generation sequencing technology.
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 | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of cases where a definite category and/or detectable mutation can be identified.
- timeFrame
- 2 years
- description
- This will be reported as a percentage of the total number of cases sequenced
Secondary outcomes (2)
- measure
- Demographics and distribution in each immunomorphological category
- timeFrame
- 2 years
- description
- Age and sex distribution will be reported along with the proportion of cases in each immunomorphologic category
- measure
- Correlation of each immunomorphological category with the mutation profile.
- timeFrame
- 2 years
- description
- The distribution of mutations within each immunomorphological category will be reported descriptively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Chronic, mature clonal B-cell malignancy that is not assignable to a specific WHO category by current technology (see flowchart in section below). Exclusion Criteria: * Non-clonal B-cell proliferation. * High grade and/or immature clonal B-cell malignancy. * Bone marrow samples with less than 20% infiltration will be excluded * Samples from patients with a known classifiable chronic B-LPD based on lymph node biopsy for e.g. staging bone marrow samples on a patient with marginal zone lymphoma. If a definitive diagnosis is established on a subsequent lymph node biopsy, patient will remain on study and this will be correlated with NGS findings. * Patient unable to provide consent for tumour and germ line samples.
References
Publications (0)
Data not yet available
No reference posted for this study.