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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00911-48 | Other Identifier | ANSM |
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Squamous cell carcinoma (HNSCC) is the most frequent form of head and neck cancer. The therapeutic choice depends on the stage of the disease and the habits of the medical teams. Surgery, radiotherapy and chemotherapy can be used, alone or combined. However, none of the existing strategies has proven its superiority.
Chemotherapy and radiotherapy induce DNA damages in the tumor cells. However, cells have the ability to induce DNA reparation, capable of causing treatment resistance. DNA reparation in non-tumor tissues can also explain the toxicity of cancer treatments.
Investigation of DNA repair pathways involved in chemo- or radiation resistance could offer a good strategy for identifying biomarkers or indicators of treatment response. This study will explore the capacity of a comprehensive functional approach that addresses several pathways, based on the use of three innovative patented technologies, to classify the tumor response of HNSCC patients to treatments according to their DNA Repair Enzyme Signature.
Our hypothesis is that taking into account various clinical parameters (e.g. patient and tumor characteristics), treatment strategy and measuring the DNA Repair Enzyme Signature would create patients' profiles and optimize their management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNA Repair enzyme signature | Other | Tumor biopsies and blood samples performed specifically to determine DNA Repair enzyme signature biomarkers profiles (CHEMRAD assay) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHEMRAD assay | Other | CHEMRAD is a new biomarker research strategy based on three assays that enables the functional characterization of DNA repair capacities. |
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| Measure | Description | Time Frame |
|---|---|---|
| DNA Repair Enzyme Signature biomarkers profiles according to intrinsic or treatment-induced radio- or chemo-resistance in different tumor and clinical settings. | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with:
The radio- or chemo-resistance will be defined as disease-free survival, i.e. absence of local or regional recurrence in irradiated tissue seen on CT-scan. The different tumor and clinical settings will be determined with:
| 18 months after the end of the treatments (approximately 24 months after the beginning of the study) |
| Measure | Description | Time Frame |
|---|---|---|
| DNA Repair Enzyme Signature biomarkers profiles according to instrinsic or treatment-induced radio- or chemo-resistance. | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble - Hôpital Michallon | Grenoble | 38043 | France | |||
| Hospices Civils de Lyon - Hôpital de la Croix Rousse |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 4 months after the end of the treatments (approximately 10 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles according to tumor response to treatment | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with:
| 4 months after the end of the treatments (approximately 10 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles according to tumor response to treatment | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with:
| 18 months after the end of the treatments (approximately 24 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles according to immediate treatment-induced toxicity | Results of DNA Repair Enzyme biomarker profiles of tumor cells will be quantified before and during treatment with:
| At the end of the treatments (an average of 6 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles of Peripheral Blood Mononuclear Cells (PBMCs). | Results of DNA repair enzyme signature of Peripheral Blood Mononuclear Cells quantified before and during treatment with:
| 4 months after the end of the treatment (approximately 10 months after the beginning of the study) |
| DNA Repair Enzyme Signature biomarkers profiles of Peripheral Blood Mononuclear Cells (PBMCs). | Results of DNA repair enzyme signature of Peripheral Blood Mononuclear Cells quantified before and during treatment with:
| 18 months after the end of the treatment (approximately 24 months after the beginning of the study) |
| Lyon |
| 69004 |
| France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Hospices Civils de Lyon | Pierre-Bénite | France |