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

University Hospital of Bordeaux

Status: Completed

Conditions: Dysplasia; Papillomavirus Infections; Cervix Cancer

Treatments: Other: Vaginal samples (biopsies + vaginal smear)

Study type: Interventional

Funder types: Other

Identifiers

NCT04072913

CHUBX 2007/08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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216 participants in 4 patient groups

Control group

Other group

Description:

Study of the expression of matrix metalloproteinases and their tissue inhibitors

Treatment:

Other: Vaginal samples (biopsies + vaginal smear)

Low grade lesion group

Other group

Description:

Study of the expression of matrix metalloproteinases and their tissue inhibitors

Treatment:

Other: Vaginal samples (biopsies + vaginal smear)

High grade lesions group

Other group

Description:

Study of the expression of matrix metalloproteinases and their tissue inhibitors

Treatment:

Other: Vaginal samples (biopsies + vaginal smear)

Cancer group

Other group

Description:

Study of the expression of matrix metalloproteinases and their tissue inhibitors

Treatment:

Other: Vaginal samples (biopsies + vaginal smear)