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

NCT ID: NCT02714920

Last Updated: 2021-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-11-23

Brief Summary

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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.

Detailed Description

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Conditions

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Head Cancer Neck Cancer

Keywords

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DNA Repair Enzyme Signature instrinsic radio- or chemo-resistance treatment-induced radio- or chemo-resistance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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DNA Repair enzyme signature

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

Group Type OTHER

CHEMRAD assay

Intervention Type OTHER

CHEMRAD is a new biomarker research strategy based on three assays that enables the functional characterization of DNA repair capacities.

Interventions

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CHEMRAD assay

CHEMRAD is a new biomarker research strategy based on three assays that enables the functional characterization of DNA repair capacities.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Grenoble - Hôpital Michallon

Grenoble, , France

Site Status

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

Hospices Civils de Lyon

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00911-48

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL15_0188

Identifier Type: -

Identifier Source: org_study_id