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NCT Number: NCT04072913

Matrix Metalloproteinases and Human Papillomavirus in Dysplasias and Cancers 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.

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Key information

Conditions

Papillomavirus Infections Cervix Cancer Communicable Diseases DNA Virus Infections Disease Attributes Dysplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Infections Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Immunohistochemical score of expressions of matrix metalloproteinases

    Time frame: 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)

  2. Immunohistochemical score of expressions of matrix metalloproteinases inhibitors

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: MMP-HPV

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Aug 28, 2019
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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