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NCT Number: NCT03896412

Detection of Circulating Tumor DNA in p16- Locally Advanced Head 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU, Rouen, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Detecton of circulating tumor DNA

Other

7 blood samples to design a molecular probe

Primary outcomes

  1. Percentage of patients with a detectable mutation in ctDNA

    Time frame: 18 months

    number of patient with detectable mutation with personalized molecular probe

Secondary outcomes

  1. Kinetics of ctDNA

    Time frame: 18 months

    Evaluation of the number of patients with an increase or decrease of circulating tumor DNA level

  2. Kinetics of ctDNA in case of relapse

    Time frame: 18 months

    Evaluation of the number of patients with an increase or decrease of circulating tumor DNA level

  3. progression free survival

    Time frame: 18 months

    time between inclusion and progression and correlation with circulating tumor DNA level

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Official study title

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

Acronym: PERSO-NECK

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Apr 1, 2019
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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