Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-07 @ 9:26 PM
Study NCT ID:
NCT01869218
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2013-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Genomic Sequencing to Find Potential Targets for Personalized Therapy
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Feasibility Study of Genomic Sequencing to Find Potential Targets for Personalized Therapy in Patients With Advanced Malignancies
Status:
COMPLETED
Status Verified Date:
2022-02
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:
This study is aimed to determine the feasibility of obtaining and molecularly characterizing pre-treatment tumor biopsies, to determine the feasibility of obtaining and molecularly characterizing archival and post-treatment tumor biopsies, to assess molecular expression changes between archival and baseline tumor samples, and to assess molecular expression changes between tumor samples obtained at baseline and at the time of disease progression.
Detailed Description:
This study will be a companion study to existing phase I clinical trial treatment studies. It is being done to determine the feasibility of obtaining tumor tissue for genomic analysis. Patient will be offered enrollment into this trial at the time that they are being considered for participation in a phase I treatment trial. After consenting for this study, patients will undergo a fresh tumor biopsy and collection of research blood samples. Archived tumor specimens will also be obtained and analyzed. At the time of disease progression, fresh tumor biopsies and blood samples will be collected in patients who have evaluable pre-biopsy specimens and who are eligible to be screened for another study. This will be informative to evaluate the mechanisms of resistance to that agent.
Study Oversight
Has Oversight DMC:
True
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?: