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Matrix Metalloproteinases and Human Papillomavirus in Dysplasias and Cancers of the Cervix (MMP-HPV)

Primary Purpose

Papillomavirus Infections, Dysplasia, Cervix Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vaginal samples (biopsies + vaginal smear)
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Papillomavirus Infections focused on measuring Matrix metalloproteinases

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

For control group:

  • Age between 20 and 65 years
  • Patients hospitalized for partial or total removal of the cervix
  • Absence of cervical lesion observed on biopsy or hysterectomy
  • Free, informed and written consent, dated and signed by the patient and the investigator (at the latest before any examination required by the study)
  • Affiliate or beneficiary of a social security scheme

For dysplasia and cancer group:

  • Age between 20 and 65 years
  • Cervical Intraepithelial Neoplasia or previously untreated cervical cancer
  • Free, informed and written consent, dated and signed by the patient and the investigator (at the latest before any examination required by the study)
  • Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

For control group:

  • History of laser or conisation
  • Known antecedent of HIV infection
  • Congenital or acquired immunodepression
  • Long-term treatment with corticosteroids or immunosuppressants
  • Persons placed under the protection of justice

For dysplasia and cancer group:

  • History of laser or conisation
  • Pre-treatment of invasive cancers by radiotherapy or chemotherapy
  • Known antecedent of HIV infection
  • Congenital or acquired immunodepression
  • Long-term treatment with corticosteroids or immunosuppressants
  • Persons placed under the protection of justice

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    Control group

    Low grade lesion group

    High grade lesions group

    Cancer group

    Arm Description

    Study of the expression of matrix metalloproteinases and their tissue inhibitors

    Study of the expression of matrix metalloproteinases and their tissue inhibitors

    Study of the expression of matrix metalloproteinases and their tissue inhibitors

    Study of the expression of matrix metalloproteinases and their tissue inhibitors

    Outcomes

    Primary Outcome Measures

    Immunohistochemical score of expressions of matrix metalloproteinases
    The immunohistochemical score is the modified HScore, also called Quickscore. It is calculated by multiplying the percentage of cells that are marked (from 0 to 100) by intensity (from 0 to 3). The total score is between 0 and 300. This score will be defined on normal, tumoral and stromal cells according to the analyzed tissue (normal, dysplasias or cancer)
    Immunohistochemical score of expressions of matrix metalloproteinases inhibitors
    The immunohistochemical score is the modified HScore, also called Quickscore. It is calculated by multiplying the percentage of cells that are marked (from 0 to 100) by intensity (from 0 to 3). The total score is between 0 and 300. This score will be defined on normal, tumoral and stromal cells according to the analyzed tissue (normal, dysplasias or cancer)

    Secondary Outcome Measures

    Full Information

    First Posted
    August 26, 2019
    Last Updated
    August 27, 2019
    Sponsor
    University Hospital, Bordeaux
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04072913
    Brief Title
    Matrix Metalloproteinases and Human Papillomavirus in Dysplasias and Cancers of the Cervix
    Acronym
    MMP-HPV
    Official Title
    Involvement of Matrix Metalloproteinases and Association With the Expression of Human Papillomavirus in Dysplasias and Cancers of the Cervix
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 10, 2007 (Actual)
    Primary Completion Date
    January 31, 2011 (Actual)
    Study Completion Date
    January 31, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Bordeaux

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to compare the expression of matrix metalloproteinases and their tissue inhibitors between 4 groups of patients defined according to the severity of the cervical lesion.
    Detailed Description
    Cervical cancer is the second most common cancer among European women under 45 years old. It is secondary to cervical dysplasia induced by persistent human papillomavirus infection. The involvement of matrix metalloproteinases in carcinogenesis of the cervix is real, but their expressions vary according to the published series. An association between the expression of MMPs and that of the human papillomavirus deserves to be explored, as this can have a prognostic influence in the case of gradual expression demonstrated in the development of (pre) cancerous lesions of the cervix. This study aims to compare the expression of matrix metalloproteinases and their tissue inhibitors between 4 groups of patients defined according to the severity of the cervical lesion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Papillomavirus Infections, Dysplasia, Cervix Cancer
    Keywords
    Matrix metalloproteinases

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    216 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Other
    Arm Description
    Study of the expression of matrix metalloproteinases and their tissue inhibitors
    Arm Title
    Low grade lesion group
    Arm Type
    Other
    Arm Description
    Study of the expression of matrix metalloproteinases and their tissue inhibitors
    Arm Title
    High grade lesions group
    Arm Type
    Other
    Arm Description
    Study of the expression of matrix metalloproteinases and their tissue inhibitors
    Arm Title
    Cancer group
    Arm Type
    Other
    Arm Description
    Study of the expression of matrix metalloproteinases and their tissue inhibitors
    Intervention Type
    Other
    Intervention Name(s)
    Vaginal samples (biopsies + vaginal smear)
    Intervention Description
    Two types of samples are envisaged: tissue (large biopsies, coin of conization or hysterectomy) to affirm the diagnosis and detect the matrix metalloproteinases and their tissue inhibitors by immunohistochemistry; cell sample (monolayer smear type) to evaluate the expression of oncogenic Human papillomavirus.
    Primary Outcome Measure Information:
    Title
    Immunohistochemical score of expressions of matrix metalloproteinases
    Description
    The immunohistochemical score is the modified HScore, also called Quickscore. It is calculated by multiplying the percentage of cells that are marked (from 0 to 100) by intensity (from 0 to 3). The total score is between 0 and 300. This score will be defined on normal, tumoral and stromal cells according to the analyzed tissue (normal, dysplasias or cancer)
    Time Frame
    At the screening
    Title
    Immunohistochemical score of expressions of matrix metalloproteinases inhibitors
    Description
    The immunohistochemical score is the modified HScore, also called Quickscore. It is calculated by multiplying the percentage of cells that are marked (from 0 to 100) by intensity (from 0 to 3). The total score is between 0 and 300. This score will be defined on normal, tumoral and stromal cells according to the analyzed tissue (normal, dysplasias or cancer)
    Time Frame
    At the screening

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Study on cervix
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: For control group: Age between 20 and 65 years Patients hospitalized for partial or total removal of the cervix Absence of cervical lesion observed on biopsy or hysterectomy Free, informed and written consent, dated and signed by the patient and the investigator (at the latest before any examination required by the study) Affiliate or beneficiary of a social security scheme For dysplasia and cancer group: Age between 20 and 65 years Cervical Intraepithelial Neoplasia or previously untreated cervical cancer Free, informed and written consent, dated and signed by the patient and the investigator (at the latest before any examination required by the study) Affiliate or beneficiary of a social security scheme Exclusion Criteria: For control group: History of laser or conisation Known antecedent of HIV infection Congenital or acquired immunodepression Long-term treatment with corticosteroids or immunosuppressants Persons placed under the protection of justice For dysplasia and cancer group: History of laser or conisation Pre-treatment of invasive cancers by radiotherapy or chemotherapy Known antecedent of HIV infection Congenital or acquired immunodepression Long-term treatment with corticosteroids or immunosuppressants Persons placed under the protection of justice
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jean-Luc BRUN, Dr
    Organizational Affiliation
    University Hospital, Bordeaux
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Matrix Metalloproteinases and Human Papillomavirus in Dysplasias and Cancers of the Cervix

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