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

NCT ID: NCT04072913

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-10
• Study Completion Date: 2011-01-31

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.

Conditions

Papillomavirus Infections; Dysplasia; Cervix Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control group

Study of the expression of matrix metalloproteinases and their tissue inhibitors

Group Type: OTHER

Vaginal samples (biopsies + vaginal smear)

Intervention Type: OTHER

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.

Low grade lesion group

Study of the expression of matrix metalloproteinases and their tissue inhibitors

Group Type: OTHER

Vaginal samples (biopsies + vaginal smear)

Intervention Type: OTHER

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.

High grade lesions group

Study of the expression of matrix metalloproteinases and their tissue inhibitors

Group Type: OTHER

Vaginal samples (biopsies + vaginal smear)

Intervention Type: OTHER

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.

Cancer group

Study of the expression of matrix metalloproteinases and their tissue inhibitors

Group Type: OTHER

Vaginal samples (biopsies + vaginal smear)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Luc BRUN, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Other Identifiers

CHUBX 2007/08

Identifier Type: -

Identifier Source: org_study_id