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Clinical Trials/NCT04072913
NCT04072913
Completed
Not Applicable

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

University Hospital, Bordeaux0 sites216 target enrollmentOctober 10, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Papillomavirus Infections
Sponsor
University Hospital, Bordeaux
Enrollment
216
Primary Endpoint
Immunohistochemical score of expressions of matrix metalloproteinases inhibitors
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 10, 2007
End Date
January 31, 2011
Last Updated
6 years ago
Study Type
Interventional
Study Design
Sequential
Sex
Female

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

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)

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

Outcomes

Primary Outcomes

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)

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)

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