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

NCT00682552 | Terminated

• 2 other identifiers: 2007-A01336-482007-31
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

• The detection and the quantification of the DNA of the human oncogènes papillomavirus of type 16 and 18

  48 months

Secondary Outcomes (1)

• The detection of the markers of the integration of the genome of the human oncogenes papillomavirus (targeted at the gene E2)

  48 months

Study Arms (1)

1

EXPERIMENTAL

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.

Procedure: A cervico-vaginal cervical smear

Interventions

A cervico-vaginal cervical smear PROCEDURE

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.

1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hopital Nord- Service de gynécologie-obstétrique

Marseille, 13015, France

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Xavier CARCOPINO, MD

  Assistance Publique des Hopitaux de Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 22, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: August 28, 2014

Record last verified: 2014-08

Locations

FR (1)