Significance of the High-risk Hpv Viral Load

NCT00682812 | Completed

• 2 other identifiers: 2007-A01335-482007-30
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HPV Infections

Outcome Measures

Primary Outcomes (1)

• Estimate the meaning of a viral load raised in HPV oncogenic

  36 months

Secondary Outcomes (4)

• 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

  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

  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

  36 months

Study Arms (3)

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

2 cervical takings and 2 sampling of blood OTHER

* 2 cervical takings * 2 sampling of blood before and after the total hysterectomy

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hopital Nord, service de gynécologie-obstétrique

Marseille, 13015, France

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xavier CARCOPINO, MD

  Assistance Publique des Hopitaux de Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2008
• First Posted: May 22, 2008
• Study Start: June 16, 2008
• Primary Completion: April 24, 2014
• Study Completion: May 23, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

FR (1)