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

Not Applicable

Completed

• Conditions: Papillomavirus Infections; Dysplasia; Cervix Cancer
• Interventions: Other: Vaginal samples (biopsies + vaginal smear)

• Registration Number: NCT04072913
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study Start: 2007-10-10
• Primary Completion: 2011-01-31
• Study Completion: 2011-01-31
• Status Verified: 2019-08
• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-27
• Last Update Submitted: 2019-08-27
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 216

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Control group	Vaginal samples (biopsies + vaginal smear)	Study of the expression of matrix metalloproteinases and their tissue inhibitors
High grade lesions group	Vaginal samples (biopsies + vaginal smear)	Study of the expression of matrix metalloproteinases and their tissue inhibitors
Low grade lesion group	Vaginal samples (biopsies + vaginal smear)	Study of the expression of matrix metalloproteinases and their tissue inhibitors
Cancer group	Vaginal samples (biopsies + vaginal smear)	Study of the expression of matrix metalloproteinases and their tissue inhibitors

Primary Outcome Measures

Name	Time	Method
Immunohistochemical score of expressions of matrix metalloproteinases inhibitors	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	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)