Detection of Circulating Tumor DNA in p16- Locally Advanced Head Neck Squamous Cell Carcinoma (PERSO-NECK)

Centre Henri Becquerel

Status: Completed

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Other: Detecton of circulating tumor DNA

Study type: Interventional

Funder types: Other

Identifiers

NCT03896412

CHB18.03

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Detection of circulating tumor DNA

Experimental group

Description:

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

Treatment:

Other: Detecton of circulating tumor DNA