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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714920
Recruitment Status : Active, not recruiting
First Posted : March 22, 2016
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE March 16, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date January 29, 2020
Actual Study Start Date  ICMJE May 2016
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
DNA Repair Enzyme Signature biomarkers profiles according to intrinsic or treatment-induced radio- or chemo-resistance in different tumor and clinical settings. [ Time Frame: 18 months after the end of the treatments (approximately 24 months after the beginning of the study) ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • DNA Repair Enzyme Signature biomarkers profiles according to instrinsic or treatment-induced radio- or chemo-resistance. [ Time Frame: 4 months after the end of the treatments (approximately 10 months after the beginning of the study) ]
    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.
  • DNA Repair Enzyme Signature biomarkers profiles according to tumor response to treatment [ Time Frame: 4 months after the end of the treatments (approximately 10 months after the beginning of the study) ]
    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.
  • DNA Repair Enzyme Signature biomarkers profiles according to tumor response to treatment [ Time Frame: 18 months after the end of the treatments (approximately 24 months after the beginning of the study) ]
    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.
  • DNA Repair Enzyme Signature biomarkers profiles according to immediate treatment-induced toxicity [ Time Frame: At the end of the treatments (an average of 6 months after the beginning of the study) ]
    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.
  • DNA Repair Enzyme Signature biomarkers profiles of Peripheral Blood Mononuclear Cells (PBMCs). [ Time Frame: 4 months after the end of the treatment (approximately 10 months after the beginning of the study) ]
    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.
  • DNA Repair Enzyme Signature biomarkers profiles of Peripheral Blood Mononuclear Cells (PBMCs). [ Time Frame: 18 months after the end of the treatment (approximately 24 months after the beginning of the study) ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DNA Repair Enzyme Signature in Head and Neck Cancer (CHEMRAD)
Official Title  ICMJE DNA Repair Enzyme Signature Associated With Response to Chemo- and Radio-therapy in Head and Neck Cancer: ChemRadAssay
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Head Cancer
  • Neck Cancer
Intervention  ICMJE Other: CHEMRAD assay
CHEMRAD is a new biomarker research strategy based on three assays that enables the functional characterization of DNA repair capacities.
Study Arms  ICMJE DNA Repair enzyme signature
Tumor biopsies and blood samples performed specifically to determine DNA Repair enzyme signature biomarkers profiles (CHEMRAD assay)
Intervention: Other: CHEMRAD assay
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 1, 2019)
38
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2016)
120
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02714920
Other Study ID Numbers  ICMJE 69HCL15_0188
2015-A00911-48 ( Other Identifier: ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP