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

Non-Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02788084
• Other study ID #: CC-16-0582
• Status: Active, not recruiting
• Start date: October 2016
• Est. completion date: June 2021

Study information

• Verified date: January 2020
• Source: Alberta Health Services, Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 2021
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Health Services, Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2 year Progression Free Survival	Recorded in percentage. To determine impact of lymphoma specific mutation on outcome.	2 years from diagnosis of B cell non-Hodgkin Lymphoma
Primary	2 year Overall Survival	Recorded in percentage. To determine impact of lymphoma specific mutation on outcome.	2 years from diagnosis of B cell non-Hodgkin Lymphoma
Primary	Occurrence of lymphoma specific mutations or detectable IgH rearrangements in circulating tumor specific DNA in blood samples at baseline	Proportion of cases of BNHL with somatic mutations or IgH gene rearrangements detectable in blood. Will be recorded in percentage, and determined at baseline.	Determined at baseline