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Trial record 6 of 228 for:    circulating dna | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02788084
Recruitment Status : Recruiting
First Posted : June 2, 2016
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Gwynivere Davies, Alberta Health Services, Calgary

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.

Condition or disease
Non-Hodgkin Lymphoma

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
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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.



Primary Outcome Measures :
  1. 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. 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.

  3. 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
DNA library, RNA and formalin fixed paraffin embedded (FFPE) specimens will be banked with participants' prior permission.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
Contact: Etienne Mahe, MD, FRCPC 4039445290 etienne.mahe@cls.ab.ca
Contact: Doug Stewart, MD, FRCPC 4035213723 douglas.stewart@albertahealthservices.ca

Locations
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada
Contact: Etienne Mahe       etienne.mahe@cls.ab.ca   
Sponsors and Collaborators
Alberta Health Services, Calgary
Investigators
Principal Investigator: Etienne Mahe, MD, FRCPC Calgary Laboratory Services, University of Calgary

Responsible Party: Gwynivere Davies, Resident, Alberta Health Services, Calgary
ClinicalTrials.gov Identifier: NCT02788084     History of Changes
Other Study ID Numbers: CC-16-0582
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gwynivere Davies, Alberta Health Services, Calgary:
Next Generation Sequencing
Cell free DNA

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases