NCT04072913

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2011

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

3.3 years

First QC Date

August 26, 2019

Last Update Submit

August 27, 2019

Conditions

Papillomavirus InfectionsDysplasiaCervix Cancer

Keywords

Matrix metalloproteinases

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Control group

OTHER

Study of the expression of matrix metalloproteinases and their tissue inhibitors

Other: Vaginal samples (biopsies + vaginal smear)

Low grade lesion group

OTHER

Study of the expression of matrix metalloproteinases and their tissue inhibitors

Other: Vaginal samples (biopsies + vaginal smear)

High grade lesions group

OTHER

Study of the expression of matrix metalloproteinases and their tissue inhibitors

Other: Vaginal samples (biopsies + vaginal smear)

Cancer group

OTHER

Study of the expression of matrix metalloproteinases and their tissue inhibitors

Other: Vaginal samples (biopsies + vaginal smear)

Interventions

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.

Cancer groupControl groupHigh grade lesions groupLow grade lesion group

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy on cervix
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Papillomavirus InfectionsUterine Cervical Neoplasms

Interventions

BiopsyVaginal Smears

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesDiagnostic Techniques, Obstetrical and Gynecological

Study Officials

  • Jean-Luc BRUN, Dr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2019

First Posted

August 28, 2019

Study Start

October 10, 2007

Primary Completion

January 31, 2011

Study Completion

January 31, 2011

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share