Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02788084
Status:
UNKNOWN
Last Update Posted:
2020-01-10
First Post:
2016-05-25
Brief Title:
Development of a Tissue-Based Cell Free DNA Next-Generation Sequencing Workflow
Sponsor:
Alberta Health Services Calgary
Organization:
Alberta Health Services Calgary
Study Overview
Official Title:
Development of a Tissue-Based Cell Free DNA Next-Generation Sequencing Workflow
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None