An interventional study of blood sampling in Locally Advanced Head and Neck Carcinoma, sponsored by Centre Jean Perrin. Recruiting at 4 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Centre Jean Perrin · Not applicable, Interventional, and Screening
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 :
Selection Criteria:
Biological: blood sampling
The intervention consist in blood samples (18mL) collected 1 and 3-months after the end of chemoradiotherapy
cDNA detection and objective response 3 months 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)
Time frame: 3 months after chemoradiotherapy
cDNA detection and objective response one 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)
Time frame: 1 month after the end of chemoradiotherapy
Overall survival
The overall survival is defined as the time between the date of inclusion and the date of death from any cause.
Time frame: At the end of the main study (27 months after the end of treatment)
Progression-free survival
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.
Time frame: At the end of the main study (27 months after the end of treatment)
cDNA kinetic
cDNA detection at 1 and 3 months after the end of chemoradiotherapy
Time frame: 1- and 3-month after the end of chemoradiotherapy
Concordance of mutational profiles and HPV-HR genotypes between primary tumor, ctDNA at diagnosis and ctDNA
This will be evaluated according to the mutational profile determined by NGS at each timepoint
Time frame: 1- and 3-months after the end of chemoradiotherapy
Determining the most frequent mutations.
That will be evaluated by analysing the results of NGS (among the 194 genes in our panel)
Time frame: 3-months after the end of chemoradiotherapy
Plan to share: Yes — The datasets used and/or analysed in the current study are available from the corresponding author on reasonable request.
Supporting information: Study protocol, Icf, Csr
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Centre Jean Perrin