Innovation for Standard Identification of Insertional HPV Mutations and of Target Therapeutic Genes in Cervical Cancer: Towards Development of Personalized Biomarkers in Clinical Oncology

Study Overview
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Brief Summary
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Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.

Detailed Description
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Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease.

Official Title
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Innovation for Standard Identification for Insertional HPV Mutations and of Target Therapeutic Genes in Cervical Cance: Towards Development of Personalized Biomarkers in Clinical Oncology (PAIR HPV : Human PapillomaVirus)

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: Tumor biopsy
* Procedure: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with cervical cancer, at any stage, before any anti-tumoral treatment. Age ≥ 18 years. Patient information and signature of the informed consent or her/his legal representative. Patient having given her/his agreement for a second biopsy at diagnosis if the first one was performed outside of the center and was not cryopreserved. Exclusion Criteria: Person deprived of liberty or under supervision. Inability to attend scheduled follow-up visits for any psychological, sociological or geographical reasons.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tumor biopsies and blood sampling<br> | Procedure: Tumor biopsy<br>* Tumor biopsy before treatment<br>Procedure: Blood sampling<br>* Blood sample before, during and after treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification and follow-up of circulating tumoral DNA in serum and/or plasma of patients with cervical cancer compared to the early detection of minimal metastatic disease. | Detection rate of circulating tumoral DNA with confidence interval of 95% of this rate. Description of the variability of this rate according to the initial stage of the disease, treatment and disease progression. | Until 2 years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of NGS methodology for the molecular characterization of genetic alterations related to the integration of viral DNA sequences. | Correlation between the two PCR/NGS detection methods - appreciation of the NGS method sensitivity compared to the PCR. | Until 2 years after treatment | 
| Detailed molecular characterization of genes alterations implicated in cervical oncogenesis. | The characterization of HPV types and HPV integration sites as well as the sequencing of representative panel of genes involved in the tumorigenesis pattway. | Until 2 years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients with cervical cancer