Locally Advanced Head and Neck Carcinoma
Conditions
Keywords
circulating DNA, residual disease
Brief summary
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
Interventions
BIOLOGICALblood sampling
The intervention consist in blood samples (18mL) collected 1 and 3-months after the end of chemoradiotherapy
Sponsors
Centre Jean Perrin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
All the patients will have a blood sample collected one month after the end of chemoradiotherapy and another at three months (excepted if already done in the main study NeckTAR, e.g., if patient have residual disease and an indication for salvage adenectomy).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Selection Criteria: * Patient included in NeckTAR study * Written informed consent signed for NeckTAR-IN study * Affiliation to the French social security system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cDNA detection and objective response 3 months after the end of chemoradiotherapy | 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
| Measure | Time frame | Description |
|---|---|---|
| cDNA detection and objective response one month after the end of chemoradiotherapy | 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) |
| Overall survival | 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. |
| Progression-free survival | 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. |
| cDNA kinetic | 1- and 3-month after the end of chemoradiotherapy | cDNA detection at 1 and 3 months after the end of chemoradiotherapy |
| Concordance of mutational profiles and HPV-HR genotypes between primary tumor, ctDNA at diagnosis and ctDNA | 1- and 3-months after the end of chemoradiotherapy | This will be evaluated according to the mutational profile determined by NGS at each timepoint |
| Determining the most frequent mutations. | 3-months after the end of chemoradiotherapy | That will be evaluated by analysing the results of NGS (among the 194 genes in our panel) |
Countries
France
Contacts
CONTACTAngeline GINZAC COUVÉ Project manager, PhD
STUDY_DIRECTORMaureen BERNADACH Coordinator, MD
Centre Jean Perrin
Outcome results
None listed