Clinical trial NCT02714920: DNA Repair Enzyme Signature in Head and Neck Cancer (CHEMRAD)
Official title: DNA Repair Enzyme Signature Associated With Response to Chemo- and Radio-therapy in Head and Neck Cancer: ChemRadAssay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Cancer
Neck Cancer
Keywords: DNA Repair Enzyme Signature
instrinsic radio- or chemo-resistance
treatment-induced radio- or chemo-resistance
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: DNA Repair Enzyme Signature biomarkers profiles according to intrinsic or treatment-induced radio- or chemo-resistance in different tumor and clinical settings.
timeFrame: 18 months after the end of the treatments (approximately 24 months after the beginning of the study)
Secondary outcomes:
measure: DNA Repair Enzyme Signature biomarkers profiles according to instrinsic or treatment-induced radio- or chemo-resistance.
timeFrame: 4 months after the end of the treatments (approximately 10 months after the beginning of the study)
measure: DNA Repair Enzyme Signature biomarkers profiles according to tumor response to treatment
timeFrame: 4 months after the end of the treatments (approximately 10 months after the beginning of the study)
measure: DNA Repair Enzyme Signature biomarkers profiles according to tumor response to treatment
timeFrame: 18 months after the end of the treatments (approximately 24 months after the beginning of the study)
measure: DNA Repair Enzyme Signature biomarkers profiles according to immediate treatment-induced toxicity
timeFrame: At the end of the treatments (an average of 6 months after the beginning of the study)
measure: DNA Repair Enzyme Signature biomarkers profiles of Peripheral Blood Mononuclear Cells (PBMCs).
timeFrame: 4 months after the end of the treatment (approximately 10 months after the beginning of the study)
measure: DNA Repair Enzyme Signature biomarkers profiles of Peripheral Blood Mononuclear Cells (PBMCs).
timeFrame: 18 months after the end of the treatment (approximately 24 months after the beginning of the study)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble - Hôpital Michallon
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Centre Léon Bérard
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon
Study officials:
References: