Clinical trial NCT02788084: Development of a Tissue-Based & Cell Free DNA Next-Generation Sequencing Workflow
Official title: Development of a Tissue-Based & Cell Free DNA Next-Generation Sequencing Workflow
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Hodgkin Lymphoma
Keywords: Next Generation Sequencing
Cell free DNA
Lead sponsor: Alberta Health Services, Calgary
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 years or older with new diagnosis of B cell non Hodgkin lymphoma (NHL) with follow up occurring in Calgary undergoing chemotherapy.

Brief summary: 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.

Detailed description: Patients with newly diagnosed B cell NHL will be identified. Samples will be cored from their diagnostic FFPE blocks and assayed to find lymphoma specific variants and immunoglobulin heavy chain gene rearrangements. Blood samples collected at baseline will be compared to see if variants and rearrangements can be detected in tumor specific DNA based on previous studies. Participant data will be collected, and clinical outcomes will be assessed to determine effect of mutation profiles on outcomes over 2 year follow up.

Blood samples will be prospectively collected at scheduled follow up and if primary objectives of this study are met, will be assessed for presence of cfDNA and impact of variation on clinical outcomes.

Eligibility criteria: 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

Primary outcomes:
measure: 2 year Progression Free Survival
timeFrame: 2 years from diagnosis of B cell non-Hodgkin Lymphoma
measure: 2 year Overall Survival
timeFrame: 2 years from diagnosis of B cell non-Hodgkin Lymphoma
measure: Occurrence of lymphoma specific mutations or detectable IgH rearrangements in circulating tumor specific DNA in blood samples at baseline
timeFrame: Determined at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
Study officials:
affiliation: Calgary Laboratory Services, University of Calgary
name: Etienne Mahe, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: