Actively Recruiting
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
Led by UNICANCER · Updated on 2025-09-19
420
Participants Needed
16
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, defined as either undetectable HPV16 Ct-DNA with no residual disease on imaging, undetectable HPV16 Ct-DNA with suspicious imaging but no persistent disease confirmed by biopsy or repeated imaging, or positive HPV16 Ct-DNA with no residual disease on imaging but negative HPV16 Ct-DNA on a subsequent assessment 1-2 months later
- Patient must be affiliated to a Social Security System or equivalent
- Patients must have signed a written informed consent form or have consent confirmed by a trusted person if physically unable
You will not qualify if you...
- Uncontrolled intercurrent illness limiting compliance with study requirements
- Active invasive malignancy within 3 years except for surgically cured non-invasive cancers such as non-melanomatous skin carcinoma or ductal carcinoma in situ of the breast
- Any other HPV induced cancer within 5 years
- Any condition jeopardizing patient participation, including lack of contraception for patients with child-bearing potential, pregnancy, or breastfeeding
- Patient unwilling or unable to comply with study protocol and follow-up schedule
- Participation in another clinical trial with an investigational medical product within 30 days prior to inclusion and during the study, except for control arm with placebo or authorized products
- Patient deprived of liberty or under protective custody or guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Clinique St Vincent- Réunion
Saint-Denis, La Réunion, France
Active, Not Recruiting
2
ISC Avignon
Avignon, France
Actively Recruiting
3
Georges-François Leclerc
Dijon, France
Actively Recruiting
4
Oscar Lambret- Lille
Lille, France
Not Yet Recruiting
5
La Timone-AP-HM Marseille
Marseille, France
Actively Recruiting
6
Antoine Lacassagne - NICE
Nice, France
Active, Not Recruiting
7
CHU De Nîmes ICG
Nîmes, France
Active, Not Recruiting
8
Hôpital Européen Georges Pompidou
Paris, France
Actively Recruiting
9
Institut Curie - Paris
Paris, France
Not Yet Recruiting
10
TENON - APHP Paris
Paris, France
Actively Recruiting
11
Eugène Marquis-Rennes
Rennes, France
Actively Recruiting
12
ICO - Site St Herblain
Saint-Herblain, France
Not Yet Recruiting
13
ICANS Strasbourg
Strasbourg, France
Actively Recruiting
14
IUCT Oncopole Toulouse
Toulouse, France
Actively Recruiting
15
Institut de cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Actively Recruiting
16
Gustave Roussy
Villejuif, France
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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