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

Not Applicable

Terminated

• Conditions: Cervical Cancer
• Interventions: Procedure: Tumor biopsy; Procedure: Blood sampling

• Registration Number: NCT02554565
• Lead Sponsor: Institut Curie

Brief Summary

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

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 Timeline

• Study Start: 2014-07-29
• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Primary Completion: 2018-09-27
• Study Completion: 2018-09-27
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumor biopsies and blood sampling	Tumor biopsy	-
Tumor biopsies and blood sampling	Blood sampling	-

Primary Outcome Measures

Name	Time	Method
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.	Until 2 years after treatment	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.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Centre François Baclesse; 🇫🇷 Caen, France

CHU Besançon; 🇫🇷 Besancon, France

Centre Jean Perrin; 🇫🇷 Clermont Ferrand, France

Institut Curie; 🇫🇷 Paris, France