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Completed

NCT Number: NCT00682812

Significance of the High-risk Hpv Viral Load

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Nord, service de gynécologie-obstétrique

Marseille, 13015, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 cervical takings and 2 sampling of blood

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

Primary outcomes

  1. Estimate the meaning of a viral load raised in HPV oncogenic

    Time frame: 36 months

Secondary outcomes

  1. To estimate the correlation enters the vorale load of the HPV oncogenic and the severity of the cervical hurt

    Time frame: 36 months

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2008
Primary completion
2014
Study completion
2023
First posted
May 22, 2008
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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