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

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00682552
• Other study ID #: 2007-A01336-48
• Secondary ID: 2007-31
• Status: Terminated
• Phase: N/A
• First received: May 19, 2008
• Last updated: August 27, 2014
• Start date: May 2008
• Est. completion date: February 2013

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Neoplasms
• Uterine Cervical Dysplasia

Intervention

Procedure:
• A cervico-vaginal cervical smear
12 and 18 months after inclusion, a cervico-vaginal cervical smear will be realized and a new examination colposcopique with a new cervical taking for the search(research) and the detection of the HPV 16 and 18.

Locations

Country	Name	City	State
France	Hopital Nord- Service de gynécologie-obstétrique	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18		48 months	Yes
Secondary	The detection of the markers of the integration of the genome of the human oncogenes papillomavirus (targeted at the gene E2)		48 months	Yes