Detection of Circulating Tumor DNA in p16- Locally Advanced Head Neck Squamous Cell Carcinoma (PERSO-NECK)
Detection of Circulating Tumor DNA by a Personalized Molecular Tool During Treatment of Locally Advanced Operable Head and Neck Squamous Cell Carcinoma
Locally advanced head and neck squamous cell carcinoma (LAHNSCC) is a heterogeneous disease, associated with a poor prognosis and no improvement in overall survival for years. Furthermore, treatments (surgery, radiotherapy, chemotherapy) are frequently associated with acute and late toxicities. Beside p16/HPV + tumors, only TNM classification can help estimating the prognosis of the patients. A better evaluation of the prognosis and of the risk of metastatic spread would help defining the best treatment.
Circulating tumor DNA (ctDNA) has been reported as both a prognostic factor and a non-invasive way to assess tumor relapse in several cancer types. Few data are available in HNSCC, and no data among p16/HPV- cancers. Indeed, ctDNA assessment is usually based on tumor mutation monitoring. But if recurrent mutations are frequent in several cancers types (PIK3CA, KRAS, ESR1, TERT…), there is no recurrent mutation observed in HNSCC. Thus ctDNA assessment in LAHNSCC must be performed after the identification of a tumor specific mutation for each patient.
In that context, the aim of this study is to perform a molecular analysis of primary LAHNSCC, and to look for the amount of ctDNA before surgery, after surgery, and during 18 months of follow up.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The patients will be enrolled before surgery and follow-up during 18 months. During patient participation, 20 ml of blood will be collected 7 times (before and after surgery, 6 months after diagnosis and every 3 months thereafter until 18 months of follow up).
Mutation analysis on tumor and healthy tissue will be performed on primary tumors and lymph node dissection, after removal by the surgeon.
Circulating tumor DNA will be detected on blood sample
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Rouen, France, 76000
- Centre Henri Becquerel
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Rouen, France, 76000
- CHU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Operable Head and neck squamous cell carcinoma (T3-T4 stage and/or N+)
- No p16 expression
- Curative treatment proposed based on surgery + radiotherapy (+/- chemotherapy)
- PS<3
- Written consent signed
Exclusion Criteria:
- Metastatic spread
- Previous radiotherapy of head or neck
- Previous HNSCC (except carcinoma restricted to glottis, with a surgery treatment alone and >3 years of follow up without relapse)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Detection of circulating tumor DNA
sampling of 20 ml of blood the day before surgery, the day after , 6 months after diagnosis and every 3 months thereafter until 18 months of follow up
|
7 blood samples to design a molecular probe
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of patients with a detectable mutation in ctDNA
Time Frame: 18 months
|
number of patient with detectable mutation with personalized molecular probe
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinetics of ctDNA
Time Frame: 18 months
|
Evaluation of the number of patients with an increase or decrease of circulating tumor DNA level
|
18 months
|
|
Kinetics of ctDNA in case of relapse
Time Frame: 18 months
|
Evaluation of the number of patients with an increase or decrease of circulating tumor DNA level
|
18 months
|
|
progression free survival
Time Frame: 18 months
|
time between inclusion and progression and correlation with circulating tumor DNA level
|
18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Flrorian Clatot, MD,PhD, Centre Henri Becquerel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHB18.03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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