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NCT Number: NCT07178847

cDNA and Residual Disease After Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinomas

The goal of this ancillary clinical trial is to evaluated circulating DNA as a biomarker of residual disease after chemoradiotherapy for locally advanced head and neck squamous cell carninoma.

The main question it aims to answer is :

- Does circulating DNA (cDNA) be able to detect residual disease 3 months after the end of chemoradiotherapy ? Researchers will compare detection of cDNA at 3-months and objective response (clinical and radiological).

Participants will :

* be included in the main study (Neck-TAR) * have a blood sample 1 and 3-month after the end of treatment

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Key information

Conditions

Locally Advanced Head and Neck Carcinoma Neoplasm, Residual Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Henri Mondor Aurillac, Aurillac, CANTAL, France

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Who can participate

Healthy volunteers accepted: No

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

Selection Criteria:

  • Patient included in NeckTAR study
  • Written informed consent signed for NeckTAR-IN study
  • Affiliation to the French social security system

Treatment and study plan

Blood sampling

Biological

The intervention consist in blood samples (18mL) collected 1 and 3-months after the end of chemoradiotherapy

Primary outcomes

  1. cDNA detection and objective response 3 months after the end of chemoradiotherapy

    Time frame: 3 months after chemoradiotherapy

    The detection or non detection of cDNA after treatment will be compared with the objective response (complete response versus progression/stability/partial response)

Secondary outcomes

  1. cDNA detection and objective response one month after the end of chemoradiotherapy

    Time frame: 1 month after the end of chemoradiotherapy

    The detection or non detection of cDNA after treatment will be compared with the objective response (complete response versus progression/stability/partial response)

  2. Overall survival

    Time frame: At the end of the main study (27 months after the end of treatment)

    The overall survival is defined as the time between the date of inclusion and the date of death from any cause.

  3. Progression-free survival

    Time frame: At the end of the main study (27 months after the end of treatment)

    The progression-free survival is defined as the time between the date of inclusion and the date of the first progression of the disease (clinical or radiological) or death from any cause.

  4. cDNA kinetic

    Time frame: 1- and 3-month after the end of chemoradiotherapy

    cDNA detection at 1 and 3 months after the end of chemoradiotherapy

  5. Concordance of mutational profiles and HPV-HR genotypes between primary tumor, ctDNA at diagnosis and ctDNA

    Time frame: 1- and 3-months after the end of chemoradiotherapy

    This will be evaluated according to the mutational profile determined by NGS at each timepoint

  6. Determining the most frequent mutations.

    Time frame: 3-months after the end of chemoradiotherapy

    That will be evaluated by analysing the results of NGS (among the 194 genes in our panel)

Study contacts

Contact information is provided by the study sponsor or research team.

Angeline GINZAC COUVÉ Project manager, PhD

CONTACT

[email protected]

0463663337 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Official study title

Evaluation of Circulating DNA as a Biomarker of Residual Disease After Chemoradiotherapy for Locally Advanced Head and Necksquamous Cell Carcinoma

Acronym: NeckTAR-IN

Important dates

Study start
2025
Primary completion
2029
Study completion
2031
First posted
Sep 17, 2025
Registry last updated
Jul 13, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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