Development of a Tissue-Based & Cell Free DNA Next-Generation Sequencing Workflow
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02788084|
Recruitment Status : Recruiting
First Posted : June 2, 2016
Last Update Posted : June 27, 2017
- Develop a Next-Generation Sequencing (NGS) workflow for mutation profiling of formalin-fixed paraffin-embedded (FFPE) tissue and cell-free DNA (cfDNA) specimens.
- 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.
- Determine if certain types of BNHL are more likely to have mutation profiles common to both FFPE & corresponding cfDNA ("FFPE-cfDNA dyads")
- 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.
|Condition or disease|
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|
|Estimated Enrollment :||80 participants|
|Official Title:||Development of a Tissue-Based & Cell Free DNA Next-Generation Sequencing Workflow|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
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.
- 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 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.
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788084
|Contact: Etienne Mahe, MD, FRCPCfirstname.lastname@example.org|
|Contact: Doug Stewart, MD, FRCPCemail@example.com|
|Tom Baker Cancer Centre||Recruiting|
|Calgary, Alberta, Canada|
|Contact: Etienne Mahe firstname.lastname@example.org|
|Principal Investigator:||Etienne Mahe, MD, FRCPC||Calgary Laboratory Services, University of Calgary|