Ignite Creation Date:
2024-05-06 @ 7:14 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02499458
Status:
COMPLETED
Last Update Posted:
2019-12-24
First Post:
2015-07-10
Brief Title:
Prospective Validation of Circulating Tumor Cells Circulating Endothelial Cells as Biomarkers in Renal Cancer
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Prospective Validation of Circulating Tumor Cells CTCs and Circulating Endothelial Cells CECs as Prognostic Biomarkers in Clear Cell Renal Cancer
Status:
COMPLETED
Status Verified Date:
2019-12
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:
Circulating tumor cells CTCs have prognostic value in several tumor types and increasing evidence suggests that molecular characterization of CTCs can serve as a liquid biopsy to understand and address treatment resistance The goal of this proposal is to demonstrate that CTCs can be accurately enumerated and characterized in metastatic clear cell renal cancer CCRC and can serve as prognosticpredictive biomarkers to improve treatment The challenge surrounding CTC analysis in CCRC is that most CTC technologies including the clinical gold-standard CellSearch depend in epithelial markers such as EpCAM that are expressed at low or heterogeneous levels in CCRC Members of the research team have developed a novel CTC microfluidic technology that can effectively detect CTCs that are completely undetectable by CellSearch because of very low EpCAM expression as well as allowing for CTC recovery for downstream molecular characterization The goal of this proposal is therefore to test the hypotheses that 1 The microfluidics CTC technology will have better sensitivityspecificity relative to the CellSearch in metastatic CCRC and 2 Enumeration of CTCs in metastatic CCRC patients n66 will have prognostic value while molecular characterization of CTCs for expression of biomarkers VHL VEGF mTOR HIF1HIF2 AKT related to CCRC etiology will be predictive of responseresistance to targeted therapies Although CCRC is relatively uncommon the lack of established adjuvant treatments and high cost of targeted therapies in the palliative setting makes the search for new prognosticpredictive biomarkers an important clinical goal
Detailed Description:
None
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