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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Papillomavirus Infections, Dysplasia, Cervix Cancer

Intervention / Treatment
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* Other: Vaginal samples (biopsies + vaginal smear)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>Study of the expression of matrix metalloproteinases and their tissue inhibitors | Other: Vaginal samples (biopsies + vaginal smear)<br>* 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.<br>|
| Other: Low grade lesion group<br>Study of the expression of matrix metalloproteinases and their tissue inhibitors | Other: Vaginal samples (biopsies + vaginal smear)<br>* 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.<br>|
| Other: High grade lesions group<br>Study of the expression of matrix metalloproteinases and their tissue inhibitors | Other: Vaginal samples (biopsies + vaginal smear)<br>* 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.<br>|
| Other: Cancer group<br>Study of the expression of matrix metalloproteinases and their tissue inhibitors | Other: Vaginal samples (biopsies + vaginal smear)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunohistochemical score of expressions of matrix metalloproteinases | 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) | At the screening | 
| Immunohistochemical score of expressions of matrix metalloproteinases inhibitors | 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) | At the screening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Matrix metalloproteinases