Significance of the High-risk Hpv Viral Load

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: HPV Infections

Treatments: Other: 2 cervical takings and 2 sampling of blood

Study type: Interventional

Funder types: Other

Identifiers

NCT00682812

2007-30

2007-A01335-48

Details and patient eligibility

About

The aim of this study is to evaluate the significance of an elevated high-risk HPV (HR-HPV) viral load.

Full 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

Enrollment: 149 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

149 participants in 3 patient groups

1

Active Comparator group

Description:

125 womens with normal cervix

Treatment:

Other: 2 cervical takings and 2 sampling of blood

Other: 2 cervical takings and 2 sampling of blood

Other: 2 cervical takings and 2 sampling of blood

2

Other group

Description:

105 womens with an intraepithelial lesion

Treatment:

Other: 2 cervical takings and 2 sampling of blood

Other: 2 cervical takings and 2 sampling of blood

Other: 2 cervical takings and 2 sampling of blood

3

Other group

Description:

105 womens with a cancer of the cervix

Treatment:

Other: 2 cervical takings and 2 sampling of blood

Other: 2 cervical takings and 2 sampling of blood

Other: 2 cervical takings and 2 sampling of blood