Blood Biomarkers Based Screening for HPV-driven OPC

NCT06528353 | Not Yet Recruiting DMC

• 1 other identifier: ORL 16
• Study Type: interventional
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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 and/or 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.

Conditions

Head and Neck Squamous Cell Carcinoma; Anal Cancer; Human Papilloma Virus

Keywords

HPV-induced cancer; Head and Neck Cancers; virology; serology; secondary cancer prevention

Outcome Measures

Primary Outcomes (1)

• Early identification of HPV-driven OPC lesions

  The efficacy of this stepwise, biomarker-based screening approach to identify and treat early HPV-driven OPC lesions in asymptomatic individuals at high risk is determined by the number (and percentage) of participants who are positive for both HPV EA serology and HPV ctDNA, AND who have a successful identification of a tumor lesion.

  3 months following last prophylactic surgery

Study Arms (2)

Control group

OTHER

For the first 500 participants enrolled, one additional blood sample will be drawn in DNA-free tubes for HPV ctDNA analysis. As we expect to have around 1% seropositive cases, most of these 500 samples will be seronegative and will constitute our control group. These controls will be tested for HPV ctDNA to confirm that seronegative participants are also HPV ctDNA-negative

Diagnostic Test: HPV16-E6 serology and HPV ctDNA

Experimental Group

EXPERIMENTAL

Individuals who are seropositive for HPV16-E6 will be contacted to propose the participation in the second part of the study and benefit from specific assessment and monitoring for 5 years (HPV ctDNA testing, regular clinical examinations of the head \& neck and anal-genital regions, imaging if needed).

Diagnostic Test: HPV16-E6 serology and HPV ctDNA

Interventions

HPV16-E6 serology and HPV ctDNA DIAGNOSTIC_TEST

In the event of a malignant lesion identified on clinical examination and/or imaging, treatment will be performed according to the standard of care. In the absence of any suspicious lesion, but in the event of HPV ctDNA positivity, prophylactic surgery of the tonsils and base of the tongue (the vast majority of HPV-related OPC develop in these regions) will be proposed to the patient, given the high risk of OPC. In case of refusal of this prophylactic surgery, close clinical and imaging monitoring will be performed. Surgical specimens will be analyzed to confirm or not the presence of HPV-driven OPC and HPV ctDNA will be measured post-operatively to ensure disease clearance.

Control group; Experimental Group

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥50 years from the general population
• Man
• No previous history of HPV-driven cancer or head neck cancer
• Willingness to complete follow up visits

You may not qualify if:

• Aged \< 50 years
• Woman
• History of HPV-driven cancer or head and neck cancer
• Psychiatric conditions
• Inability to complete follow up visits
• Severe medical condition (life expectancy \<5 years)
• Previous prophylactic HPV vaccination

Sponsors & Collaborators

• UNICANCER: lead

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Anus Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Study Officials

• Haïtham Mirghani

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michaël CHEVROT

CONTACT

0171936161; m-chevrot@unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): January 1, 2032
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share