DNA Repair Enzyme Signature in Head and Neck Cancer (CHEMRAD)

Civil Hospices of Lyon

Status: Completed

Conditions: Head Cancer; Neck Cancer

Treatments: Other: CHEMRAD assay

Study type: Interventional

Funder types: Other

Identifiers

NCT02714920

69HCL15_0188

2015-A00911-48 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 years old;
• HNSCC proven on a biopsy, located in the oral cavity or the oropharynx (the tumor must be accessible to a biopsy during an outpatient visit);
• Tumor accessible to a biopsy under local anesthesia;
• TNM classification: any stage except M1;
• Eligible for radiotherapy as a curative treatment;
• No surgery planned as exclusive treatment;
• Able to comply with the scheduled visits;
• Affiliated to or beneficiary of a social security system (or equivalent) ;
• Having given written informed consent prior to any procedure related to the study.

Exclusion criteria

• Recurrence or second cancer in a previously irradiated area;
• Nasopharyngeal carcinoma;
• Tumor requiring general anesthesia to perform the biopsy;
• Radiotherapy planned to be provided outside of the investigation center;
• Pregnant or lactating woman;
• Adult ward of court (under guardianship or trusteeship).

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

DNA Repair enzyme signature

Other group

Description:

Tumor biopsies and blood samples performed specifically to determine DNA Repair enzyme signature biomarkers profiles (CHEMRAD assay)

Treatment:

Other: CHEMRAD assay