Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
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.
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
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