HPV InfectionsNCT00682812
Significance of the High-risk Hpv Viral Load
A study testing 2 cervical takings and 2 sampling of blood in people with HPV Infections, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The aim of this study is to evaluate the significance of an elevated high-risk HPV (HR-HPV) viral load. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HPV Infections
- What is being tested?
- 2 cervical takings and 2 sampling of blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2008to 23 May 2023
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The women consulting for the therapeutic care (by hysterectomy or conization) of a LIEHG or a cervical cancer (carcinoma epidermoid or adenocarcinoma) confirmed by the anatomopathologique analysis of a preoperative cervical biopsy.
- The women having a normal cervix consulting for the surgical care by hysterectomy of a good-hearted pathology of the womb. The normality of the cervix will be confirmed by the anatomopathologique analysis of the detail of hysterectomy
- The patients participating in this study will have to be of more than 18 years old. All the subjects will be profitable of a regime of Social Security.
Who cannot join
- The patients having a LIEBG
- The patients incapable to receive the information enlightened on the progress and the objectives of the study
- The patients not having signed enlightened assent
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the significance of an elevated high-risk HPV (HR-HPV) viral load.
Read the detailed description
We will particularly evaluate if the HR-HPV viral load:
- Is correlated to the transcription of the genes of the oncoproteins E6 and E7
- Is predictive of the integration of the virus in infected cells
- Is predictive of the presence of HPV in patients' blood
- Influences the local and systemic immunologic response
- Conditions
- HPV Infections
- Being tested
- 2 cervical takings and 2 sampling of blood
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 cervical takings and 2 sampling of bloodOther
- 2 cervical takings
- 2 sampling of blood before and after the total hysterectomy
2 cervical takings and 2 sampling of bloodOther
- cervical taking during the cervical conization
- 2 sampling of blood before and after the intervention
2 cervical takings and 2 sampling of bloodOther
- cervical taking during the pelvien examination under general anesthetic realized systematically during the balance sheet of pre-therapeutic evaluation
- 2 sampling of blood before and after the intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 125 womens with normal cervix Receives: Other: 2 cervical takings and 2 sampling of blood |
| 2 | Other | 105 womens with an intraepithelial lesion Receives: Other: 2 cervical takings and 2 sampling of blood |
| 3 | Other | 105 womens with a cancer of the cervix Receives: Other: 2 cervical takings and 2 sampling of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the meaning of a viral load raised in HPV oncogenic
Measured: 36 months
Secondary outcomes (4)
To estimate the correlation enters the vorale load of the HPV oncogenic and the severity of the cervical hurt
Measured: 36 months
Estimate the correlation between the viral load of the HPV oncogenic and the level of transcription of the genes coding for oncoproteines E6 and E7
Measured: 36 months
Estimate the correlation between the viral load in HPV oncogenic and the integration of the viral genome in that of the infected cells
Measured: 36 months
Estimate the correlation between a viral load raised in HPV oncogenic and a presence of HPV in the circulating blood of the infected patients
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study start16 Jun 2008
- Primary completion24 Apr 2014
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionsStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier CARCOPINO, MD, Principal investigator, Assistance Publique des Hopitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682812
- Sponsor's protocol ID
- 2007-A01335-48
- Other IDs
- 2007-30
- Status last verified
- May 2023
- First submitted
- 20 May 2008
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of the High-risk Hpv Viral Load
- ClinicalTrials.gov ID
- NCT00682812
- Acronym / sponsor ID
- 2007-A01335-48
- Conditions
- HPV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 16 Jun 2008 (actual)
- Primary completion
- 24 Apr 2014 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 22 May 2008 (estimated)
- 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.
The aim of this study is to evaluate the significance of an elevated high-risk HPV (HR-HPV) viral load.
Detailed description
We will particularly evaluate if the HR-HPV viral load:
- Is correlated to the transcription of the genes of the oncoproteins E6 and E7
- Is predictive of the integration of the virus in infected cells
- Is predictive of the presence of HPV in patients' blood
- Influences the local and systemic immunologic response
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: 2 cervical takings and 2 sampling of blood125 womens with normal cervix |
| 2 | Other | Other: 2 cervical takings and 2 sampling of blood105 womens with an intraepithelial lesion |
| 3 | Other | Other: 2 cervical takings and 2 sampling of blood105 womens with a cancer of the cervix |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The women consulting for the therapeutic care (by hysterectomy or conization) of a LIEHG or a cervical cancer (carcinoma epidermoid or adenocarcinoma) confirmed by the anatomopathologique analysis of a preoperative cervical biopsy.
- The women having a normal cervix consulting for the surgical care by hysterectomy of a good-hearted pathology of the womb. The normality of the cervix will be confirmed by the anatomopathologique analysis of the detail of hysterectomy
- The patients participating in this study will have to be of more than 18 years old. All the subjects will be profitable of a regime of Social Security.
Key exclusion criteria (3 listed)
- The patients having a LIEBG
- The patients incapable to receive the information enlightened on the progress and the objectives of the study
- The patients not having signed enlightened assent
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 |
|---|---|---|
| 2 cervical takings and 2 sampling of blood* 2 cervical takings * 2 sampling of blood before and after the total hysterectomy | Other | 1 |
| 2 cervical takings and 2 sampling of blood* cervical taking during the cervical conization * 2 sampling of blood before and after the intervention | Other | 2 |
| 2 cervical takings and 2 sampling of blood* cervical taking during the pelvien examination under general anesthetic realized systematically during the balance sheet of pre-therapeutic evaluation * 2 sampling of blood before and after the intervention | Other | 3 |
Primary outcome
Estimate the meaning of a viral load raised in HPV oncogenic
Time frame: 36 months
4 secondary outcomes
To estimate the correlation enters the vorale load of the HPV oncogenic and the severity of the cervical hurt
Time frame: 36 months
Estimate the correlation between the viral load of the HPV oncogenic and the level of transcription of the genes coding for oncoproteines E6 and E7
Time frame: 36 months
Estimate the correlation between the viral load in HPV oncogenic and the integration of the viral genome in that of the infected cells
Time frame: 36 months
Estimate the correlation between a viral load raised in HPV oncogenic and a presence of HPV in the circulating blood of the infected patients
Time frame: 36 months
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 May 2023.
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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.
Xavier CARCOPINO, MD principal investigator
Assistance Publique des Hopitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 cervical takings and 2 sampling of blood in people with HPV Infections, run by Assistance Publique Hopitaux De Marseille 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 3 inclusion and 3 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 May 2023. 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?
Estimate the meaning of a viral load raised in HPV oncogenic (time frame: 36 months). 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 May 2023.