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

Institut Curie26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cervical Cancer

Interventions

Tumor biopsyPROCEDURE

Tumor biopsy before treatment

Blood samplingPROCEDURE

Blood sample before, during and after treatment

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patient with cervical cancer, at any stage, before any anti-tumoral treatment. 2. Age ≥ 18 years. 3. Patient information and signature of the informed consent or her/his legal representative. 4. 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: 1. Person deprived of liberty or under supervision. 2. Inability to attend scheduled follow-up visits for any psychological, sociological or geographical reasons.

Locations (4)

CHU Besançon

Besançon, France

Centre François Baclesse

Caen, France

Centre Jean Perrin

Clermont-Ferrand, France

Institut Curie

Paris, France

Outcomes

Primary Outcomes

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.

Time frame: Until 2 years after treatment

Secondary Outcomes

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.

Time frame: 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.

Time frame: Until 2 years after treatment

Data from ClinicalTrials.gov

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