Clinical trial · Observational
Development of a Tissue-Based & Cell Free DNA Next-Generation Sequencing Workflow
- 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)
1. Develop a Next-Generation Sequencing (NGS) workflow for mutation profiling of formalin-fixed paraffin-embedded (FFPE) tissue and cell-free DNA (cfDNA) specimens. 2. Calculate the proportion of cases in a test series of B-cell non-Hodgkin Lymphomas (BNHL) with somatic mutations or immunoglobulin heavy chain (IGH) gene rearrangements common to both FPPE and cfDNA specimens. 3. Determine if certain types of BNHL are more likely to have mutation profiles common to both FFPE \& corresponding cfDNA ("FFPE-cfDNA dyads") 4. Determine if specific mutations or mutation profiles in FFPE or cfDNA specimens (or both) are of prognostic value after a clinical follow-up of 2 years from the time of diagnosis.
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 |
|---|---|---|---|
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- B cell Non-Hodgkin Lymphoma
- description
- 18 years of age or older with new diagnosis of non-Hodgkin lymphoma with FFPE specimen demonstrating enough tissue for elucidation of lymphoma specific variant and immunoglobulin clonotype, willing to provide baseline and follow up bloodwork to look for presence of variant and clonotype.
Primary outcomes (3)
- measure
- 2 year Progression Free Survival
- timeFrame
- 2 years from diagnosis of B cell non-Hodgkin Lymphoma
- description
- Recorded in percentage. To determine impact of lymphoma specific mutation on outcome.
- measure
- 2 year Overall Survival
- timeFrame
- 2 years from diagnosis of B cell non-Hodgkin Lymphoma
- description
- Recorded in percentage. To determine impact of lymphoma specific mutation on outcome.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * New diagnosis of B cell NHL * Willing to have blood collected at timepoints of regularly scheduled follow up * Formalin fixed paraffin embedded (FFPE) diagnostic specimen sufficient for further testing Exclusion Criteria: * Unwilling or unable to participate in follow up
References
Publications (0)
Data not yet available