Development of a Tissue-Based & Cell Free DNA Next-Generation Sequencing Workflow

NCT ID: NCT02788084

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2021-06-30

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.

Conditions

Non-Hodgkin Lymphoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

B cell Non-Hodgkin Lymphoma

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alberta Health Services, Calgary

OTHER

Sponsor Role: lead

Responsible Party

Gwynivere Davies

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Etienne Mahe, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Calgary Laboratory Services, University of Calgary

Locations

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

CC-16-0582

Identifier Type: -

Identifier Source: org_study_id