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

August 27, 2019 updated by: University Hospital, Bordeaux

Involvement of Matrix Metalloproteinases and Association With the Expression of Human Papillomavirus in Dysplasias and Cancers 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Study of the expression of matrix metalloproteinases and their tissue inhibitors
Other: Vaginal samples (biopsies + vaginal smear)
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.
Other: Low grade lesion group
Study of the expression of matrix metalloproteinases and their tissue inhibitors
Other: Vaginal samples (biopsies + vaginal smear)
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.
Other: High grade lesions group
Study of the expression of matrix metalloproteinases and their tissue inhibitors
Other: Vaginal samples (biopsies + vaginal smear)
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.
Other: Cancer group
Study of the expression of matrix metalloproteinases and their tissue inhibitors
Other: Vaginal samples (biopsies + vaginal smear)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunohistochemical score of expressions of matrix metalloproteinases
Time Frame: At the screening
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)
At the screening
Immunohistochemical score of expressions of matrix metalloproteinases inhibitors
Time Frame: At the screening
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)
At the screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Jean-Luc BRUN, Dr, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2007

Primary Completion (Actual)

January 31, 2011

Study Completion (Actual)

January 31, 2011

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2007/08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Papillomavirus Infections

Clinical Trials on Vaginal samples (biopsies + vaginal smear)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe