Papillomavirus InfectionsMMP-HPVNCT04072913
Matrix Metalloproteinases and Human Papillomavirus in Dysplasias and Cancers of the Cervix
A study testing Vaginal samples (biopsies + vaginal smear) in people with Papillomavirus Infections and Dysplasia, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Papillomavirus Infections, Dysplasia, Cervix Cancer
- What is being tested?
- Vaginal samples (biopsies + vaginal smear)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2007to 31 Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Involvement of Matrix Metalloproteinases and Association With the Expression of 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.
Read the 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.
- Conditions
- Papillomavirus Infections, Dysplasia, Cervix Cancer
- Being tested
- Vaginal samples (biopsies + vaginal smear)
- Keywords
- Matrix metalloproteinases
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Study of the expression of matrix metalloproteinases and their tissue inhibitors Receives: Other: Vaginal samples (biopsies + vaginal smear) |
| Low grade lesion group | Other | Study of the expression of matrix metalloproteinases and their tissue inhibitors Receives: Other: Vaginal samples (biopsies + vaginal smear) |
| High grade lesions group | Other | Study of the expression of matrix metalloproteinases and their tissue inhibitors Receives: Other: Vaginal samples (biopsies + vaginal smear) |
| Cancer group | Other | Study of the expression of matrix metalloproteinases and their tissue inhibitors Receives: Other: Vaginal samples (biopsies + vaginal smear) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: At the screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start10 Oct 2007
- Primary completion31 Jan 2011
- Study completion31 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc BRUN, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072913
- Sponsor's protocol ID
- CHUBX 2007/08
- Other IDs
- 2007-A00624-49
- Acronym
- MMP-HPV
- Status last verified
- Aug 2019
- First submitted
- 26 Aug 2019
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Matrix Metalloproteinases and Association With the Expression of Human Papillomavirus in Dysplasias and Cancers of the Cervix
- ClinicalTrials.gov ID
- NCT04072913
- Acronym / sponsor ID
- MMP-HPV / CHUBX 2007/08
- Conditions
- Papillomavirus Infections, Dysplasia, Cervix Cancer
- Keywords
- Matrix metalloproteinases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 10 Oct 2007 (actual)
- Primary completion
- 31 Jan 2011 (actual)
- Study completion
- 31 Jan 2011 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Vaginal samples (biopsies + vaginal smear)Study of the expression of matrix metalloproteinases and their tissue inhibitors |
| Low grade lesion group | Other | Other: Vaginal samples (biopsies + vaginal smear)Study of the expression of matrix metalloproteinases and their tissue inhibitors |
| High grade lesions group | Other | Other: Vaginal samples (biopsies + vaginal smear)Study of the expression of matrix metalloproteinases and their tissue inhibitors |
| Cancer group | Other | Other: Vaginal samples (biopsies + vaginal smear)Study of the expression of matrix metalloproteinases and their tissue inhibitors |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Cancer group, Control group, High grade lesions group, Low grade lesion group |
Primary outcome
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc BRUN, Dr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal samples (biopsies + vaginal smear) in people with Papillomavirus Infections and Dysplasia, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunohistochemical score of expressions of matrix metalloproteinases (time frame: At the screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.