Informations générales (source: ClinicalTrials.gov)
Detection of Circulating Tumor DNA by a Personalized Molecular Tool During Treatment of Locally Advanced Operable Head and Neck Squamous Cell Carcinoma (PERSO-NECK)
Interventional
N/A
Centre Henri Becquerel (Voir sur ClinicalTrials)
janvier 2019
mai 2022
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Henri Becquerel - 76000 - Rouen - France | Florian Clatot, Md,PhD | Contact (sur clinicalTrials) | |||
| CHU - 76000 - Rouen - France | Nicolas Bon Mardion, Md,PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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)