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

Cervix Cancer Clinical Trial

— MMP-HPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072913
• Other study ID #: CHUBX 2007/08
• Status: Completed
• Phase: N/A
• Start date: October 10, 2007
• Est. completion date: January 31, 2011

Study information

• Verified date: August 2019
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: January 31, 2011
• Est. primary completion date: January 31, 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervix Cancer
• Dysplasia
• Papillomavirus Infections
• Uterine Cervical Neoplasms

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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