Clinical trial NCT04072913: Matrix Metalloproteinases and Human Papillomavirus in Dysplasias and Cancers of the Cervix
Official title: Involvement of Matrix Metalloproteinases and Association With the Expression of Human Papillomavirus in Dysplasias and Cancers of the Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Papillomavirus Infections
Dysplasia
Cervix Cancer
Keywords: Matrix metalloproteinases
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 216
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Immunohistochemical score of expressions of matrix metalloproteinases
timeFrame: At the screening
measure: Immunohistochemical score of expressions of matrix metalloproteinases inhibitors
timeFrame: At the screening
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean-Luc BRUN, Dr
role: PRINCIPAL_INVESTIGATOR
References: