Detection of Circulating Tumor DNA in p16- Locally Advanced Head Neck Squamous Cell Carcinoma

NCT ID: NCT03896412

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-21
• Study Completion Date: 2023-01-09

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

Conditions

Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Detection of circulating tumor DNA

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

Group Type: EXPERIMENTAL

Detecton of circulating tumor DNA

Intervention Type: OTHER

7 blood samples to design a molecular probe

Interventions

Detecton of circulating tumor DNA

7 blood samples to design a molecular probe

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Henri Becquerel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Flrorian Clatot, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel

Locations

Centre Henri Becquerel

Rouen, , France

CHU

Rouen, , France

Countries

France

Other Identifiers

CHB18.03

Identifier Type: -

Identifier Source: org_study_id