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

January 7, 2020 updated by: Gwynivere Davies, Alberta Health Services, Calgary
  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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Tom Baker Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2 year Progression Free Survival
Time Frame: 2 years from diagnosis of B cell non-Hodgkin Lymphoma
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
Time Frame: 2 years from diagnosis of B cell non-Hodgkin Lymphoma
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
Time Frame: Determined 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alberta Health Services, Calgary

Investigators

  • Principal Investigator: Etienne Mahe, MD, FRCPC, Calgary Laboratory Services, University of Calgary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

June 1, 2019

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CC-16-0582

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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