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

Detection of Circulating Tumor DNA by a Personalized Molecular Tool During Treatment of Locally Advanced Operable Head and Neck Squamous Cell Carcinoma

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.

Study Overview

• Status: Unknown
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Other: Detecton of circulating tumor DNA

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florian Clatot, MD,PhD; Phone Number: +33232082231; Email: floriane.clatot@chb.unicancer.fr

Study Locations

• France
  • Rouen, France, 76000
    • Recruiting
    • Centre Henri Becquerel
  • Rouen, France, 76000
    • Recruiting
    • CHU
    • Contact: Nicolas Bon Mardion, Md,PhD; Email: nicolas.bon-mardion@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Other: Detecton of circulating tumor DNA; 7 blood samples to design a molecular probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with a detectable mutation in ctDNA	number of patient with detectable mutation with personalized molecular probe	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinetics of ctDNA	Evaluation of the number of patients with an increase or decrease of circulating tumor DNA level	18 months
Kinetics of ctDNA in case of relapse	Evaluation of the number of patients with an increase or decrease of circulating tumor DNA level	18 months
progression free survival	time between inclusion and progression and correlation with circulating tumor DNA level	18 months

Collaborators and Investigators

• Sponsor: Centre Henri Becquerel
• Investigators: Principal Investigator: Flrorian Clatot, MD,PhD, Centre Henri Becquerel

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 21, 2019
• Primary Completion (ANTICIPATED): May 19, 2021
• Study Completion (ANTICIPATED): May 19, 2022

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (ACTUAL): April 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 29, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Digital PCR; Next Generation Sequencing; circulating tumor DNA
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: CHB18.03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No