Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05370300
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2022-05-06
Brief Title:
SNAPS Breast Cancer Patient Study Breast Cancer Patients
Sponsor:
ImmunisAI
Organization:
ImmunisAI
Study Overview
Official Title:
Subtraction Normalized Aggregated Phagocytic Signal in Peripheral Blood of Breast Cancer Patients SNAPS - Clinical Trial A NextGen RNASeq Feasibility Study of a Blood-based Model for Early Cancer Detection and Surveillance
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
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:
Differential immunogenomic signatures from peripheral blood CD14 phagocytic and CD2 non-phagocytic cells have been associated with multiple cancers and disease states In particular several large clinical studies at ImmunisAI have demonstrated robust immunogenomic signatures in early-stage prostate cancer ImmunisAI therefore hypothesizes that a peripheral blood immunogenomic signature will identify patients with various stages of breast cancer from healthy negative controls
Detailed Description:
Efficient next generation RNA sequencing platforms have allowed for whole genome expression profiling of individual populations of immune cells as a novel means of searching for patterns of gene expression to aid in the identification of meaningful signals unique to various disease states Single cell sequencing techniques have provided additional information useful in deconvolution strategies applied to model development on purified populations of immune cells Recent interest in peripheral leukocyte subset gene expression profiles suggests that diagnostic information for many disorders may be contained therein Mononuclear phagocytic cells including the various CD14 subsets have been studied extensively in various disease states including some solid tumors Previous large clinical studies at ImmunisAI have determined that transcriptomic profiles of CD14 cell populations subtraction normalized from CD2 cell populations were associated with aggressive disease phenotypes such as prostate cancer Tumor heterogeneity multifocality and oligoclonality have been a significant barrier to development of meaningful tissue based multigene signatures for predicting cancer biologic behavior The findings at ImmunisAI strongly suggest that analysis of RNA expression data from the bodys immune surveillance cells has the potential to summarize the entire heterogeneous tumor The investigators believe that the CD14CD2 log ratio can be understood as a subtraction normalization of gene expression which yields superior signal of early-stage cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None