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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cDNA detection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood sampling | Biological | The intervention consist in blood samples (18mL) collected 1 and 3-months after the end of chemoradiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months after chemoradiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 month after the end of chemoradiotherapy |
| Overall survival |
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Selection Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angeline GINZAC COUVÉ Project manager, PhD | Contact | 0463663337 | +33 | angeline.ginzac@clermont.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Maureen BERNADACH Coordinator, MD | Centre Jean Perrin | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Henri Mondor Aurillac | Recruiting | Aurillac | CANTAL | 15000 | France |
The datasets used and/or analysed in the current study are available from the corresponding author on reasonable request.
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| ID | Term |
|---|---|
| D018365 | Neoplasm, Residual |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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).
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The overall survival is defined as the time between the date of inclusion and the date of death from any cause. |
| 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. | 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 | 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 | 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) | 3-months after the end of chemoradiotherapy |
| Centre Jean PERRIN | Recruiting | Clermont-Ferrand | Puy-de-Dôme | 63011 | France |
|
| Hôpital de la Croix-Rousse | Recruiting | Lyon | France |
|
| CHU de Saint-Étienne | Recruiting | Saint-Etienne | France |
|
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |