Clinical trial NCT03896412: Detection of Circulating Tumor DNA in p16- Locally Advanced Head Neck Squamous Cell Carcinoma
Official title: Detection of Circulating Tumor DNA by a Personalized Molecular Tool During Treatment of Locally Advanced Operable Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: circulating tumor DNA
Next Generation Sequencing
Digital PCR
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of patients with a detectable mutation in ctDNA
timeFrame: 18 months
Secondary outcomes:
measure: Kinetics of ctDNA
timeFrame: 18 months
measure: Kinetics of ctDNA in case of relapse
timeFrame: 18 months
measure: progression free survival
timeFrame: 18 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Rouen
country: France
facility: CHU
Study officials:
affiliation: Centre Henri Becquerel
name: Flrorian Clatot, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: