New method to monitor HPV16-related throat cancer recurrence
SURVEILLE-HPV: National, Multicenter, Open-label, Randomized, Phase II Study Evaluating HPV16 Circulating DNA as Biomarker to Detect the Recurrence, in Order to Improve Post Therapeutic Surveillance of HPV16-driven Oropharyngeal Cancers
This study is testing if measuring HPV16 DNA in the blood can help doctors better monitor throat cancer patients for signs of recurrence, so they can provide more personalized follow-up care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unicancer Academic / other |
| Locations | 16 sites (Saint-Denis, La Réunion and 15 other locations) |
| Trial ID | NCT05582122 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the use of HPV16 circulating DNA as a biomarker to improve post-therapeutic surveillance for patients with HPV-positive oropharyngeal squamous cell carcinoma. The study aims to determine if measuring HPV circulating DNA can help identify patients at risk for cancer recurrence, allowing for tailored follow-up strategies. Patients with undetectable HPV Ct-DNA may require fewer follow-up visits, while those with detectable levels may need closer monitoring. The goal is to enhance patient care and reduce healthcare costs associated with unnecessary surveillance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with p16 positive oropharyngeal squamous cell carcinoma who have completed curative treatment.
Not a fit: Patients with HPV-negative oropharyngeal cancer or those who do not meet the eligibility criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and efficient monitoring of oropharyngeal cancer patients, potentially improving early detection of recurrences.
How similar studies have performed: Other studies have shown promise in using circulating tumor DNA as a biomarker for cancer recurrence, suggesting that this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient aged 18 years or over 2. Patient with p16 positive Oropharyngeal squamous cell carcinoma (OPSCC) 3. Clinical stage T1-4, N0-3, M0 (stages I-III) 4. Any tobacco status 5. Life expectancy greater than 36 months 6. Positive HPV16 Ct-DNA measured before curative anticancer treatment 7. Treated by any curative treatment 8. 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). 9. Patient must be affiliated to a Social Security System (or equivalent) 10. 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. Exclusion Criteria: 1. Uncontrolled intercurrent illness that would limit compliance with study requirements. 2. Active invasive malignancy within 3 years of inclusion except for non-invasive malignancies such as non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured. 3. Any other HPV induced cancer within 5 years 4. 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 5. Patient unwilling or unable to comply with the study protocol and follow-up schedule. 6. Participation in another clinical trial with an investigational medical product during the last 30 days prior to the inclusion and during the present study (except if patient is included in the control arm, with placebo or with a product that have a marketed authorization, used as per the summary of product characteristics (SmPC) for the given indication). 7. Patient deprived of liberty or placed under protective custody or guardianship.
Where this trial is running
Saint-Denis, La Réunion and 15 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.