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

NCT02788084 | Unknown

• 1 other identifier: CC-16-0582
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.Determine if certain types of BNHL are more likely to have mutation profiles common to both FFPE \& corresponding cfDNA ("FFPE-cfDNA dyads")
4. 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

Non-Hodgkin Lymphoma

Keywords

Next Generation Sequencing; Cell free DNA

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Unwilling or unable to participate in follow up

Sponsors & Collaborators

• Alberta Health Services, Calgary: lead

Study Sites (1)

Tom Baker Cancer Centre

Calgary, Alberta, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA library, RNA and formalin fixed paraffin embedded (FFPE) specimens will be banked with participants' prior permission.

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Etienne Mahe, MD, FRCPC

  Calgary Laboratory Services, University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: June 2, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2021
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)