Significance of the High-risk Hpv Viral Load | NCT00682812

Studies
Significance of the High-risk Hpv Viral Load

NCT00682812

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

May 24, 2023Actual

Enrollment

149Actual

Phase

Not Applicable

Conditions

HPV Infections

Interventions

2 cervical takings and 2 sampling of blood
2 cervical takings and 2 sampling of blood
2 cervical takings and 2 sampling of blood

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-30

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2008Actual

Primary Completion Date

Apr 24, 2014Actual

Completion Date

May 23, 2023Actual

First Submitted Date

May 20, 2008

First Submission Date that Met QC Criteria

May 21, 2008

First Posted Date

May 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2023

Last Update Posted Date

May 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

149Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	125 womens with normal cervix	Other: 2 cervical takings and 2 sampling of blood
2	Other	105 womens with an intraepithelial lesion	Other: 2 cervical takings and 2 sampling of blood
3	Other	105 womens with a cancer of the cervix	Other: 2 cervical takings and 2 sampling of blood

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2 cervical takings and 2 sampling of blood	Other	2 cervical takings 2 sampling of blood before and after the total hysterectomy	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Estimate the meaning of a viral load raised in HPV oncogenic		36 months

Secondary Outcomes

Measure	Description	Time Frame
To estimate the correlation enters the vorale load of the HPV oncogenic and the severity of the cervical hurt		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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xavier CARCOPINO, MD	Assistance Publique des Hopitaux de Marseille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Nord, service de gynécologie-obstétrique		Marseille		13015	France

Condition Browse Module

MeSH Terms

ID	Term
D030361	Papillomavirus Infections

Ancestor Terms

ID	Term
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided