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

NCT04072913 — Not applicable, Completed, 216 participants, University Hospital, Bordeaux

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

RegistryNCT04072913, acronym MMP-HPV
StatusCompleted
PhaseNot applicable
Study typeInterventional; non randomized, sequential, masking: none, basic science
Enrollment216 (Actual)
SponsorUniversity Hospital, Bordeaux (Other)
ConditionsPapillomavirus Infections, Dysplasia, Cervix Cancer
InterventionsVaginal samples (biopsies + vaginal smear) (Other)
Datesstart 2007-10-10, primary completion 2011-01-31, completion 2011-01-31, first posted 2019-08-28, last updated 2026-06-24
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Papillomavirus Infections All trials for Dysplasia All trials of Vaginal samples (biopsies + vaginal smear)

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Control groupOtherOther: Vaginal samples (biopsies + vaginal smear)Study of the expression of matrix metalloproteinases and their tissue inhibitors
Low grade lesion groupOtherOther: Vaginal samples (biopsies + vaginal smear)Study of the expression of matrix metalloproteinases and their tissue inhibitors
High grade lesions groupOtherOther: Vaginal samples (biopsies + vaginal smear)Study of the expression of matrix metalloproteinases and their tissue inhibitors
Cancer groupOtherOther: Vaginal samples (biopsies + vaginal smear)Study of the expression of matrix metalloproteinases and their tissue inhibitors
  • Vaginal samples (biopsies + vaginal smear) (Other): 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.

+Outcome measures

Primary outcomes

  • Immunohistochemical score of expressions of matrix metalloproteinases [At the screening]: 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 [At the screening]: 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)

+Eligibility

Sex: Female, ages: 20 Years to 65 Years

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

+Locations (1)

FacilityCityCountryStatus
CHU de BordeauxBordeauxFrance

+Investigators

  • Jean-Luc BRUN, Dr, Principal investigator, University Hospital, Bordeaux