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


N/A
18 Years
65 Years
Open (Enrolling)
Female
Cervical Intraepithelial Neoplasia

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

48 months

Safety Issue:

Yes

Principal Investigator

Xavier CARCOPINO, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique des Hopitaux de Marseille

Authority:

France: Ministry of Health

Study ID:

2007-A01336-48

NCT ID:

NCT00682552

Start Date:

May 2008

Completion Date:

December 2012

Related Keywords:

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

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