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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00682552

Enrollment

Registered

2008-05-22

Start date

2008-05-31

Completion date

2013-02-28

Last updated

2014-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Intraepithelial Neoplasia

Brief 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.

Detailed 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.

Interventions

PROCEDUREA 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18	48 months

Secondary

Measure	Time frame
The detection of the markers of the integration of the genome of the human oncogenes papillomavirus (targeted at the gene E2)	48 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026