Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528353
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Blood Biomarkers Based Screening for HPV-driven OPC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
SCREEN-HPV Blood Biomarkers Based Screening for HPV-driven OPC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
SCREEN-HPV
Brief Summary:
The objective of our study is to demonstrate that it is possible to detect and treat human papilloma virus HPV-related oropharyngeal cancers OPC early using simple blood tests The success of this strategy will be evaluated by the number of participants positive for both HPV16-E6 serology and HPV circulating tumor DNA ctDNA whose early management has allowed the detection of a cancerous lesion andor whose HPV ctDNA results have normalized after surgical intervention If this study is conclusive it could pave the way for the implementation of a national screening strategy for HPV-related OPC
Detailed Description:
OPC caused by HPV are the most common head and neck cancers and are expected to increase in the future especially since HPV vaccines are not widely used Currently there are no screening strategy available for these cancers but developing such approaches could enable the earlier management of patients and thus improve prognosis while reducing treatment related toxicities
Traditional screening methods like imaging or examination are not effective for OPC because early lesions are undetectable However studies suggest that using certain blood tests to detect HPV-related OPC early might be efficient
Antibodies directed against a specific protein of HPV called HPV16-E6 are present in most cases of HPV-related OPC and it has been shown that they can be detected several years before the cancer diagnosis
HPV ctDNA can be found in the blood of almost all patients with HPV-related cancers After treatment HPV ctDNA can detect relapses before they are visible on imaging tests microscopic disease We propose to test the use of these two blood tests to identify individuals at high risk of developing OPC and offer them appropriate medical follow-up HPV16-E6 serology will be conducted on 10000 men over 50 years of age without symptoms who have consented to participate in the project These participants will be included during routine visits to the biomedical analysis laboratory
Individuals positive for HPV16-E6 test will be contacted approximately 100 participants They will be offered to continue the study to receive an initial assessment and regular monitoring for 5 years HPV ctDNA test regular clinical examinations imaging examinations if needed In case of identification of suspicious lesions appropriate management will be proposed according to the standard recommendations If no lesion is detected but HPV ctDNA remains positive preventive surgery may be considered
Traditional screening methods like imaging or examination are not effective for OPC because early lesions are undetectable However studies suggest that using certain blood tests to detect HPV-related OPC early might be efficient
Antibodies directed against a specific protein of HPV called HPV16-E6 are present in most cases of HPV-related OPC and it has been shown that they can be detected several years before the cancer diagnosis
HPV ctDNA can be found in the blood of almost all patients with HPV-related cancers After treatment HPV ctDNA can detect relapses before they are visible on imaging tests microscopic disease We propose to test the use of these two blood tests to identify individuals at high risk of developing OPC and offer them appropriate medical follow-up HPV16-E6 serology will be conducted on 10000 men over 50 years of age without symptoms who have consented to participate in the project These participants will be included during routine visits to the biomedical analysis laboratory
Individuals positive for HPV16-E6 test will be contacted approximately 100 participants They will be offered to continue the study to receive an initial assessment and regular monitoring for 5 years HPV ctDNA test regular clinical examinations imaging examinations if needed In case of identification of suspicious lesions appropriate management will be proposed according to the standard recommendations If no lesion is detected but HPV ctDNA remains positive preventive surgery may be considered
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