An interventional study of CHEMRAD assay in Head Cancer and Neck Cancer, sponsored by Hospices Civils de Lyon. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-27.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Screening
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 552 are open to participants now.
This study's enrollment of 38 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
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Exclusion Criteria:
Tumor biopsies and blood samples performed specifically to determine DNA Repair enzyme signature biomarkers profiles (CHEMRAD assay)
Other: CHEMRAD assay
CHEMRAD is a new biomarker research strategy based on three assays that enables the functional characterization of DNA repair capacities.
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 excision/synthesis assay, as the incorporated fluorescence intensity; * The ODN (Oligonucleotide) assay, as the percentage of cleavage for the DNA target lesions; * The DSB (Double-strand breaks) Assay, as the incorporated fluorescence intensity. 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: * Patient and tumor characteristics, i.e. age, sex, etiological factors (tobacco, alcohol), localization and stage of the tumor, HPV (Human Papilloma Virus) status, p53 status; * Treatment strategy, i.e. all the treatments that will be administered to the patient and their sequence, including International Nonproprietary Name of the drugs and doses of chemo and/or radiotherapy
Time frame: 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 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: * The excision/synthesis assay, as the incorporated fluorescence intensity; * The ODN assay, as the percentage of cleavage for the DNA target lesions; * The DSB Assay, as the incorporated fluorescence intensity. The radio- or chemo-resistance will be defined as disease-free survival, i.e. absence of local or regional recurrence in irradiated tissue measured on the CT-scan performed 4 months after the end of the treatment.
Time frame: 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: * The excision/synthesis assay, as the incorporated fluorescence intensity; * The ODN assay, as the percentage of cleavage for the DNA target lesions; * The DSB Assay, as the incorporated fluorescence intensity. Global response to treatment measured on the CT-scan according to RECIST criteria, at 4 months after the end of the treatment.
Time frame: 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: * The excision/synthesis assay, as the incorporated fluorescence intensity; * The ODN assay, as the percentage of cleavage for the DNA target lesions; * The DSB Assay, as the incorporated fluorescence intensity. Global response to treatment measured on the CT-scan according to RECIST criteria, at 18 months, after the end of the treatment.
Time frame: 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: * The excision/synthesis assay, as the incorporated fluorescence intensity; * The ODN assay, as the percentage of cleavage for the DNA target lesions; * The DSB Assay, as the incorporated fluorescence intensity. Treatment-induced adverse events occurring during the treatment.
Time frame: 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: * The ODN assay, as the percentage of cleavage for the DNA target lesions; * The DSB Assay, as the incorporated fluorescence intensity.
Time frame: 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: * The ODN assay, as the percentage of cleavage for the DNA target lesions; * The DSB Assay, as the incorporated fluorescence intensity.
Time frame: 18 months after the end of the treatment (approximately 24 months after the beginning of the study)
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon