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

NCT03896412 | Completed

• 1 other identifier: CHB18.03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

circulating tumor DNA; Next Generation Sequencing; Digital PCR

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with a detectable mutation in ctDNA

  number of patient with detectable mutation with personalized molecular probe

  18 months

Secondary Outcomes (3)

• Kinetics of ctDNA

  18 months

• Kinetics of ctDNA in case of relapse

  18 months

• progression free survival

  18 months

Study Arms (1)

Detection of circulating tumor DNA

EXPERIMENTAL

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

Interventions

Detecton of circulating tumor DNA OTHER

7 blood samples to design a molecular probe

Detection of circulating tumor DNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (2)

Centre Henri Becquerel

Rouen, 76000, France

Location

CHU

Rouen, 76000, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Flrorian Clatot, MD,PhD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: April 1, 2019
• Study Start: January 21, 2019
• Primary Completion: March 30, 2021
• Study Completion: January 9, 2023
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

FR (2)