Informations générales (source: ClinicalTrials.gov)
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 (SURVEILLE-HPV)
Interventional
Phase 2
UNICANCER (Voir sur ClinicalTrials)
avril 2024
avril 2031
24 juillet 2024
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)
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Europeen Georges Pompidou | Haïtham MIRGHANI | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Tenon | Bertrand BAUJAT | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT CURIE | Joey MARTIN | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Antoine Lacassagne - NICE - Nice - France | Contact (sur clinicalTrials) | ||||
| CHU De Nîmes ICG - Nîmes - France | Contact (sur clinicalTrials) | ||||
| Clinique St Vincent- Réunion - Saint-Denis - La Réunion - France | Contact (sur clinicalTrials) | ||||
| Eugène Marquis-Rennes - Rennes - France | Florian ESTRADE | Contact (sur clinicalTrials) | |||
| Georges-François Leclerc - Dijon - France | David THIBOUW | Contact (sur clinicalTrials) | |||
| Gustave Roussy - Villejuif - France | Pierre BLANCHARD | Contact (sur clinicalTrials) | |||
| ICANS Strasbourg - Strasbourg - France | Mickaël BURGY | Contact (sur clinicalTrials) | |||
| ICO - Site St Herblain - Saint-Herblain - France | Mélanie DORE | Contact (sur clinicalTrials) | |||
| Institut de cancérologie de Lorraine - Vandœuvre-lès-Nancy - France | Romina MASTRONICOLA | Contact (sur clinicalTrials) | |||
| ISC Avignon - Avignon - France | Benoit CALDERON | Contact (sur clinicalTrials) | |||
| IUCT Oncopole Toulouse - Toulouse - France | Anouchka MODESTO | Contact (sur clinicalTrials) | |||
| La Timone-AP-HM Marseille - Marseille - France | Sébastien SALAS | Contact (sur clinicalTrials) | |||
| Oscar Lambret- Lille - Lille - France | Samia BOUHIR | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
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.
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.