Evaluation of Initial High Risk Human Papillomavirus (HR-HPV) Viral Load as Predictive Marker for Cervical Intraepithelial Neoplasia Grade 1 (CIN1) Persistence

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Terminated

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Procedure: A cervico-vaginal cervical smear

Study type: Interventional

Funder types: Other

Identifiers

NCT00682552

2007-A01336-48

2007-31

Details and patient eligibility

About

Relationship between HPV infection and cervical cancer is well established. Among the HPV types identified to date, 15 are classified as high risk HPV (HR-HPV). Detection of HR-HPV has been proposed to optimize cervical cancer screening.

Full description

A prospective detection and quantification of HR-HPV in patients with proven CIN1 will be performed. Relationship between HR-HPV initial viral load and the CIN1 persistence will be evaluated.

Enrollment: 14 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The women whose last one FCV of screening put in evidence a LIEBG of the neck of the womb having been confirmed by the colposcopie.
• The inclusive patients will be of more than 18 years old. All the patients will be profitable of a regime of Social Security.

Exclusion criteria

• The patients whose result of the colposcopie is clashing with that of the FCV of initial screening (normal collar, LIEHG or the other one).
• The patients having an antecedent of DREGS of the neck of the womb, that this one was or not handled
• The patients having had a hysterectomy.
• 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: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

1

Experimental group

Description:

A cervico-vaginal cervical smear will be realized before every colposcopique examination. A new cervical taking for the search(research) and the detection of the HPV 16 and 18 will be realized.

Treatment:

Procedure: A cervico-vaginal cervical smear