Matrix Metalloproteinases and Human Papillomavirus in Dysplasias and Cancers of the Cervix (MMP-HPV)
Primary Purpose
Papillomavirus Infections, Dysplasia, Cervix Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vaginal samples (biopsies + vaginal smear)
Sponsored by
About this trial
This is an interventional basic science trial for Papillomavirus Infections focused on measuring Matrix metalloproteinases
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Control group
Low grade lesion group
High grade lesions group
Cancer group
Arm Description
Study of the expression of matrix metalloproteinases and their tissue inhibitors
Study of the expression of matrix metalloproteinases and their tissue inhibitors
Study of the expression of matrix metalloproteinases and their tissue inhibitors
Study of the expression of matrix metalloproteinases and their tissue inhibitors
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT04072913
First Posted
August 26, 2019
Last Updated
August 27, 2019
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04072913
Brief Title
Matrix Metalloproteinases and Human Papillomavirus in Dysplasias and Cancers of the Cervix
Acronym
MMP-HPV
Official Title
Involvement of Matrix Metalloproteinases and Association With the Expression of Human Papillomavirus in Dysplasias and Cancers of the Cervix
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2007 (Actual)
Primary Completion Date
January 31, 2011 (Actual)
Study Completion Date
January 31, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillomavirus Infections, Dysplasia, Cervix Cancer
Keywords
Matrix metalloproteinases
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
216 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Description
Study of the expression of matrix metalloproteinases and their tissue inhibitors
Arm Title
Low grade lesion group
Arm Type
Other
Arm Description
Study of the expression of matrix metalloproteinases and their tissue inhibitors
Arm Title
High grade lesions group
Arm Type
Other
Arm Description
Study of the expression of matrix metalloproteinases and their tissue inhibitors
Arm Title
Cancer group
Arm Type
Other
Arm Description
Study of the expression of matrix metalloproteinases and their tissue inhibitors
Intervention Type
Other
Intervention Name(s)
Vaginal samples (biopsies + vaginal smear)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immunohistochemical score of expressions of matrix metalloproteinases
Description
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)
Time Frame
At the screening
Title
Immunohistochemical score of expressions of matrix metalloproteinases inhibitors
Description
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)
Time Frame
At the screening
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Study on cervix
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc BRUN, Dr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Matrix Metalloproteinases and Human Papillomavirus in Dysplasias and Cancers of the Cervix
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