Trial 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
NCT ID:
NCT05582122
Condition:
Oropharynx Squamous Cell Carcinoma
Conditions: Official terms:
Oropharyngeal Neoplasms
Recurrence
Conditions: Keywords:
HPV16
CtDNA
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
HPV16 Ct-DNA dosing
Description:
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.
Arm group label:
Lightened follow-up visits frequency (9 visits over 5 years), with HPV16 Ct-DNA dosing
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)
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinique St Vincent- Réunion
Address:
City:
Saint-Denis
Country:
France
Status:
Active, not recruiting
Facility:
Name:
ISC Avignon
Address:
City:
Avignon
Country:
France
Status:
Recruiting
Contact:
Last name:
Benoit CALDERON
Phone:
04 90 27 62 74
Email:
b.calderon@isc84.org
Facility:
Name:
Georges-François Leclerc
Address:
City:
Dijon
Country:
France
Status:
Recruiting
Contact:
Last name:
David THIBOUW
Phone:
03 70 63 23 23
Email:
dthibouw@cgfl.fr
Facility:
Name:
Oscar Lambret- Lille
Address:
City:
Lille
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Samia BOUHIR
Phone:
03 20 29 59 59
Email:
s.bouhir@o-lambret.fr
Facility:
Name:
La Timone-AP-HM Marseille
Address:
City:
Marseille
Country:
France
Status:
Recruiting
Contact:
Last name:
Sébastien SALAS
Phone:
04 91 38 57 08
Email:
sebastien.salas@ap-hm.fr
Facility:
Name:
Antoine Lacassagne - NICE
Address:
City:
Nice
Country:
France
Status:
Active, not recruiting
Facility:
Name:
CHU De Nîmes ICG
Address:
City:
Nîmes
Country:
France
Status:
Active, not recruiting
Facility:
Name:
Hôpital Européen Georges Pompidou
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Haïtham MIRGHANI
Phone:
01 56 09 34 53
Email:
haitham.mirghani@aphp.fr
Facility:
Name:
Institut Curie - Paris
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Joey MARTIN
Phone:
06 89 65 30 29
Email:
joey.martin@curie.fr
Facility:
Name:
TENON - APHP Paris
Address:
City:
Paris
Country:
France
Status:
Recruiting
Contact:
Last name:
Bertrand BAUJAT
Phone:
01 56 01 64 17
Email:
bertrand.baujat@aphp.fr
Facility:
Name:
Eugène Marquis-Rennes
Address:
City:
Rennes
Country:
France
Status:
Recruiting
Contact:
Last name:
Florian ESTRADE
Phone:
02 99 25 31 82
Email:
f.estrade@rennes.unicancer.fr
Facility:
Name:
ICO - Site St Herblain
Address:
City:
Saint-Herblain
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Mélanie DORE
Phone:
02 40 67 99 00
Email:
melanie.dore@ico.unicancer.fr
Facility:
Name:
ICANS Strasbourg
Address:
City:
Strasbourg
Country:
France
Status:
Recruiting
Contact:
Last name:
Mickaël BURGY
Phone:
03 68 76 71 15
Email:
m.burgy@icans.eu
Facility:
Name:
IUCT Oncopole Toulouse
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Anouchka MODESTO
Phone:
05 31 15 54 29
Email:
modesto.anouchka@iuct-oncopole.fr
Facility:
Name:
Institut de cancérologie de Lorraine
Address:
City:
Vandœuvre-lès-Nancy
Country:
France
Status:
Recruiting
Contact:
Last name:
Romina MASTRONICOLA
Phone:
03 83 59 83 04
Email:
r.mastronicola@nancy.unicancer.fr
Facility:
Name:
Gustave Roussy
Address:
City:
Villejuif
Country:
France
Status:
Recruiting
Contact:
Last name:
Pierre BLANCHARD
Phone:
01 42 11 53 60
Email:
Pierre.BLANCHARD@gustaveroussy.fr
Start date:
April 3, 2024
Completion date:
April 1, 2031
Lead sponsor:
Agency:
UNICANCER
Agency class:
Other
Source:
UNICANCER
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05582122
