An interventional study of Detecton of circulating tumor DNA in Head and Neck Squamous Cell Carcinoma, sponsored by Centre Henri Becquerel. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Centre Henri Becquerel · Not applicable, Interventional, and Other
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
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's enrollment of 40 is below the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Centre Henri Becquerel is the lead sponsor of 57 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
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
Other: Detecton of circulating tumor DNA
7 blood samples to design a molecular probe
Percentage of patients with a detectable mutation in ctDNA
number of patient with detectable mutation with personalized molecular probe
Time frame: 18 months
Kinetics of ctDNA
Evaluation of the number of patients with an increase or decrease of circulating tumor DNA level
Time frame: 18 months
Kinetics of ctDNA in case of relapse
Evaluation of the number of patients with an increase or decrease of circulating tumor DNA level
Time frame: 18 months
progression free survival
time between inclusion and progression and correlation with circulating tumor DNA level
Time frame: 18 months
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Squamous Cell Carcinoma of Head and Neck→
Centre Henri Becquerel