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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)

Primary Purpose

Cervical Cancer

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tumor biopsy
Blood sampling
Sponsored by
Institut Curie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring Patients with cervical cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Besançon
  • Centre François Baclesse
  • Centre Jean Perrin
  • Institut Curie

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tumor biopsies and blood sampling

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 1, 2015
Last Updated
March 18, 2019
Sponsor
Institut Curie
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1. Study Identification

Unique Protocol Identification Number
NCT02554565
Brief Title
Innovation for Standard Identification of Insertional HPV Mutations and of Target Therapeutic Genes in Cervical Cancer: Towards Development of Personalized Biomarkers in Clinical Oncology
Acronym
PAIR HPV
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Study in competition with another so it was decided to stop recruitment
Study Start Date
July 29, 2014 (Actual)
Primary Completion Date
September 27, 2018 (Actual)
Study Completion Date
September 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Patients with cervical cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tumor biopsies and blood sampling
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Tumor biopsy
Intervention Description
Tumor biopsy before treatment
Intervention Type
Procedure
Intervention Name(s)
Blood sampling
Intervention Description
Blood sample before, during and after treatment
Primary Outcome Measure Information:
Title
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.
Description
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 Outcome Measure Information:
Title
Validation of NGS methodology for the molecular characterization of genetic alterations related to the integration of viral DNA sequences.
Description
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
Title
Detailed molecular characterization of genes alterations implicated in cervical oncogenesis.
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU Besançon
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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