Genotypification and Predisposing Factors in Human Papilloma Virus Infection
Condition: Intraepithelial Neoplasia
MeSH terms: Virus Diseases; Papillomavirus Infections; Neoplasms; Papilloma
Study type: Interventional

Summary: 
      Objective: Determine the genotypes and risk factors associated with human papilloma virus
      infection in Mexican women.

      Methods: It was a cross-sectional study of women attended at the Materno-Perinatal Hospital
      "Mónica Pretelini" and the Medical Research Center (CICMED), who were asked to complete a
      risk factor questionnaire and submitted to colposcopy to identify SIL. Cervical swab samples
      were obtained to perform linear array HPV genotyping test (Roche®, Mannheim, Germany).
    

Detailed description: 
      Principles: The aim of this study was to determine the HPV genotypes in squamous
      intraepithelial lesions (SIL) in a population sample of the State of Mexico.

      Patients:

      The inclusion criteria were women submitted to a colposcopy study at the Clinic 221 of the
      Mexican Social Security Institute (IMSS), Maternal-Perinatal Hospital "Monica Pretelini"
      (HMPMP), State of Mexico Health Institute (ISEM) and the Medical Research Center (CICMED),
      Autonomous University of State of México (UAEMex). Women with previous conization were not
      considered into the study and those whose clinical follow up was lost were excluded.

      Sociodemographic factors:

      Patients were given a questionnaire to measure the following potential risk factors: age,
      area of residence, education level, sexual partners, participation in anal sex, age at first
      intercourse, smoking, use of hormonal contraception, use of condoms, number of pregnancies
      and vaginal deliveries.

      Cervical samples:

      Samples were collected by cervical scraping and were preserved in ThinPrep® PreservCyt®
      Solution (HologicTM Marlborough, Massachusetts, USA).

      HPV genotyping:

      DNA extraction from the cervical swab samples was performed using the Amplicor kit (Roche®,
      Mannheim, Germany), isolating simultaneously the β-globin gene along with HPV. HPV positive
      specimens were subsequently genotyped using the Linear Array HPV Genotyping assay (Roche®,
      Mannheim, Germany). This test is a qualitative in vitro test for the detection of HPV
      utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid
      hybridization able to detect 37 anogenital HPV DNA genotypes (6, 11, 16, 18, 26, 31, 33, 35,
      39, 40, 42, 45, 51, 52, 53, 54, 55, 56, 58, 59, 61, 62, 64, 66, 67, 68, 69, 70, 71, 72, 73
      (MM9), 81, 82 (MM4), 83 (MM7), 84 (MM8), IS39 and CP6108). This technique can detect multiple
      HPV genotypes in the same sample.

      Ethical concerns:

      We followed the Declaration of Helsinki and all patients were asked to sign the written
      informed consent. This study was accepted by the Research and Ethical Committee of the
      CICMED.

      Statistical analysis:

      First, descriptive analyzes were performed, secondly, Odds Ratios (OR) and their associated
      95% confidence intervals (95% CI) were calculated as well as Chi-square tests and conditional
      regression model for SIL using the Statistical Package for the Social Sciences (SPSS) 17.0
      software. Difference was considered significant at p ≤ 0.05.
    

Intervention name(s): Linear Array HPV Genotyping assay
Intervention type(s): Other
Intervention description(s): All samples with the suspicion of squamous intraepithelial lesion were processed with the Linnear Array methodology to identify HPV genotypes
Other intervention name(s): Linnear Array methodology
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: cervical intraepithelial neoplasia, HPV, Cancer