Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04545177
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2020-03-17
Brief Title:
Improving Understanding of Brain Tumors Through Preservation of Biologically Active Brain Tissue
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Prospective Surgical Study on the Feasibility of Semi-Automated Tissue Collection Stabilization Preservation and Site Transfer - Improving Understanding of Brain Tumors Through Preservation of Biologically Active Brain Tissue
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
Recent experiments are giving researchers insight into the changes mutations that occur in an individual brain tumor cell compared to a normal cell Currently we do not have enough knowledge about how uniform these changes are throughout a single brain tumor and if different regions of a brain tumor have different groupings of changes By obtaining multiple samples of the tumor from various regions during surgery it will allow researchers to better understand these changes with the hope that they will lead to new discoveries in the diagnosis and treatment of brain tumors
Detailed Description:
This is a single site interventional cohort study to assess the feasibility of the NICO Myriad and Tissue Preservation System TPS to collect and preserve biologically active tissue in 5 prospectively-enrolled participants with Glioblastoma GBM undergoing surgical resection
The primary objective of this study is to assess the viability of tumor tissue obtained by the NICO Myriad and Tissue Preservation System TPS via an automated standardized methodology in participants undergoing surgery
The exploratory objective of this study is to assess the spatial genomic and transcriptomic heterogeneity of GBM tumors in 3 locations via preoperative annotation and stereotactic guidance
The primary objective of this study is to assess the viability of tumor tissue obtained by the NICO Myriad and Tissue Preservation System TPS via an automated standardized methodology in participants undergoing surgery
The exploratory objective of this study is to assess the spatial genomic and transcriptomic heterogeneity of GBM tumors in 3 locations via preoperative annotation and stereotactic guidance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None