SURVEILLE-HPV: Evaluation of HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers

NCT05582122 | Recruiting Phase 2 DMC

• 1 other identifier: UC-HNG-2209
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 16

Brief Summary

SURVEILLE-HPV - A new post therapeutic surveillance strategy for HPV-driven oropharyngeal cancer based on HPV Circulating DNA measures. HPV-positive oropharyngeal cancer patients have a much better prognosis that their HPV-negative counterparts. Despite this, Post Treatment Surveillance (PTS) strategy does not take into account HPV status. HPV Circulating DNA (HPV Ct DNA) has emerged as a promising tool to assess the risk of cancer recurrence following treatment. We assume that this biomarker could be helpful to guide PTS. The number of systematic PTS visits could be significantly reduced in patients with undetectable HPV Ct DNA whereas a closer clinical and radiological follow up could be performed in case of detectable HPV Ct DNA. If confirmed, this new strategy could have several benefits including:

• reduction of PTS visits for most HPV-positive patients which implies a potential cost decrease and
• Identification of relapse at early stages (before the occurrence of symptoms)

Conditions

Oropharynx Squamous Cell Carcinoma

Keywords

HPV16; CtDNA

Outcome Measures

Primary Outcomes (1)

• Negative Predictive Value (NPV) of HPV16 ct-DNA

  The presence of HPV16 ct-DNA will be evaluated by ddPCR. NPV will be defined as 2 successive HPV16 ct-DNA negative results.

  24 months

Secondary Outcomes (8)

• 5- year Negative Predictive Value

  48 and 60 months

• Positive Predictive Value (PPV) of HPV16 ct-DNA

  18, 24, 48, and 60 months

• Rate of relapses detected by HPV16 ct-DNA

  5.5 years

• Disease-free survival

  5.5 years

• Loco-Regional recurrence

  From randomization to disease recurrence, up to 5.5 years

Study Arms (2)

Standard follow-up monitoring (16 visits over 5 years)

NO INTERVENTION

Patients enrolled in the control arm will be monitored according to SFORL guidelines. Physical Examination (PE) will be carried out: \- every 2 months the 1st year, every 3 months the 2nd year, every 4 months the 3rd year, every 6 months at 4 and 5 years. Annual chest CT scan will be performed for current smokers \& for those who have quit smoking less than 15 years ago.

Lightened follow-up visits frequency (9 visits over 5 years), with HPV16 Ct-DNA dosing

EXPERIMENTAL

Physical Examinations (with HPV16 Ct-DNA dosing) planned at Months 4,8,12,18,24,30,36,48,60 post treatment. Annual chest CT scan will be performed for current smokers \& for those who have quit smoking less than 15 years ago. Any patient with a normal PE but positive HPV16 ct-DNA test during follow-up period will require a confirmation test \~1-2 months later. If HPV16 ct-DNA positivity is confirmed, an H\&N MRI /PET-CT will be performed. Then: * If MRI and PET-CT are negative, the patient will be examined every 2 months (PE and HPV16 Ct-DNA dosing) and MRI/PET-CT will be repeated every 4-6 months, until HPV16 Ct-DNA becomes undetectable. * If MRI and/or PET-CT is positive, the patient will get a biopsy to confirm disease recurrence. Once confirmed, the patient will have the necessary care, as per local practices, but will continue to be followed up within this study up to 5 years after treatment.

Biological: HPV16 Ct-DNA dosing

Interventions

HPV16 Ct-DNA dosing BIOLOGICAL

Droplet based digital PCR (ddPCR) technology is a novel method for performing digital PCR. A sample is fractionated into 20,000 droplets, PCR amplification of the template molecules occurs in each individual droplet. ddPCR allows to generate quantitative and accurate data without standard curves and also present higher sensitivity compared to conventional quantitative PCR (qPCR). Indeed, this method is based on the realization of millions of single-molecule PCRs in parallel in independent compartment (here droplets of an emulsion) and consequently avoids the bias seen in conventional PCR. ddPCR offers an optimized approach for the sensitive detection and quantification of low-target-abundance biological samples. DNA extraction will be planned on 1 mL of plasma, which will further increase the sensitivity of our technique initially based on only 200µL of DNA extracted plasma.

Lightened follow-up visits frequency (9 visits over 5 years), with HPV16 Ct-DNA dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 years or over
• Patient with p16 positive Oropharyngeal squamous cell carcinoma (OPSCC)
• Clinical stage T1-4, N0-3, M0 (stages I-III)
• Any tobacco status
• Life expectancy greater than 36 months
• Positive HPV16 Ct-DNA measured before curative anticancer treatment
• Treated by any curative treatment
• Complete response at 3 months after end of treatment, which means:
• Undetectable HPV16 Ct-DNA and no residual disease on imaging (group A) or
• Undetectable HPV16 Ct-DNA and suspicious imaging but persistent disease excluded by either biopsy or repeated imaging (group B1) or
• Positive HPV16 Ct-DNA and no residual disease on imaging but negative HPV16 Ct-DNA on the subsequent assessment. This second test will be done 1-2 months after the first one (group C1).
• Patient must be affiliated to a Social Security System (or equivalent)
• Patients must have signed a written informed consent form prior to any trial specific procedures. If the patient is physically unable to give his/her written consent, a trusted person of his/her choice, note related to the investigator or the sponsor, can confirm in writing the patient's consent.

You may not qualify if:

• Uncontrolled intercurrent illness that would limit compliance with study requirements.
• Any other HPV induced cancer within 5 years
• Any condition that may jeopardize the patient participation as well as non-contraception for male and female with child-bearing potential, pregnancy or breast-feeding
• Patient unwilling or unable to comply with the study protocol and follow-up schedule.
• Patient deprived of liberty or placed under protective custody or guardianship.

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (16)

Clinique St Vincent- Réunion

Saint-Denis, La Réunion, France

ACTIVE NOT RECRUITING

ISC Avignon

Avignon, France

RECRUITING

Georges-François Leclerc

Dijon, France

RECRUITING

Oscar Lambret- Lille

Lille, France

NOT YET RECRUITING

La Timone-AP-HM Marseille

Marseille, France

RECRUITING

Antoine Lacassagne - NICE

Nice, France

ACTIVE NOT RECRUITING

CHU De Nîmes ICG

Nîmes, France

ACTIVE NOT RECRUITING

Hôpital Européen Georges Pompidou

Paris, France

RECRUITING

Institut Curie - Paris

Paris, France

NOT YET RECRUITING

TENON - APHP Paris

Paris, France

RECRUITING

Eugène Marquis-Rennes

Rennes, France

RECRUITING

ICO - Site St Herblain

Saint-Herblain, France

NOT YET RECRUITING

ICANS Strasbourg

Strasbourg, France

RECRUITING

IUCT Oncopole Toulouse

Toulouse, France

RECRUITING

Institut de cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

RECRUITING

Gustave Roussy

Villejuif, France

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 17, 2022
• Study Start: April 3, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2031
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (16)