Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606028
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Tumor-Informed ctDNA Testing of Head Neck Intent Treatment of Squamous Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Tumor-informed ctDNA Testing for Minimal Residual Disease Monitoring Following Curative-intent Treatment of Squamous Cell Carcinoma of the Head and Neck
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center non-interventional observational study that evaluates the correlation of circulating tumor DNA ctDNA testing to cancer relapse for participants with head and neck squamous cell carcinomas HNC after curative-intent primary radiation or surgery
Detailed Description:
PRIMARY OBJECTIVE
I To determine the rates of detectable ctDNA within two years of participants treated with curative-intent surgery or radiation-based treatment for HNC
SECONDARY OBJECTIVES
1 To describe the prevalence of detectable ctDNA at initial diagnosis in participants with HNC
2 To describe the association of quantitative ctDNA levels with time-to-event outcomes overall survival OS disease-free survival DFS and time to recurrence TTR
3 To describe the association of quantitative ctDNA levels with follow-up imaging tumor volume
OUTLINE
Participants will have tissue samples collected at screening and blood samples collected for analysis before during and after non-investigational standard of care treatment for cancer for up to 2 years
I To determine the rates of detectable ctDNA within two years of participants treated with curative-intent surgery or radiation-based treatment for HNC
SECONDARY OBJECTIVES
1 To describe the prevalence of detectable ctDNA at initial diagnosis in participants with HNC
2 To describe the association of quantitative ctDNA levels with time-to-event outcomes overall survival OS disease-free survival DFS and time to recurrence TTR
3 To describe the association of quantitative ctDNA levels with follow-up imaging tumor volume
OUTLINE
Participants will have tissue samples collected at screening and blood samples collected for analysis before during and after non-investigational standard of care treatment for cancer for up to 2 years
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