Genotypification and Predisposing Factors in Human Papilloma Virus Infection

Brief Title

Genotypification and Predisposing Factors in Human Papilloma Virus Infection

Official Title

Genotypification and Predisposing Factors in Human Papilloma Virus Infection and Its Association With the Carbohydrate Antigen (CA-125) Tumoral Marker

Brief 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.
    

Study Type

Interventional

Primary Outcome

Multiple HPV infection

Secondary Outcome

 squamous intraepithelial lesions

Condition

Intraepithelial Neoplasia

Intervention

Linear Array HPV Genotyping assay

Study Arms / Comparison Groups

 Linear Array HPV Genotyping assay

Description:  Women submitted to colposcopy with a suspicion of squamous intraepithelial lesion were programmed a clinical follow up to cervical swab in order to extract DNA and perform a Linear Array HPV Genotyping assay (Roche®, Mannheim, Germany).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Other

Estimated Enrollment

129

Start Date

February 2011

Completion Date

October 2011

Primary Completion Date

May 2011

Eligibility Criteria

        Inclusion Criteria:

          -  Sexually active women 18 to 40 years of age who come to consult the dysplasia clinic.

          -  Who are not pregnant

          -  Who have not received pharmacological treatment with antibiotics and / or
             anti-inflammatory drugs at least one month before the study.

          -  Who agreed to participate in the study and signed the informed consent letter.

          -  Acceptance to fill the questionnaire with relevant data related to HPV risk infection

        Exclusion Criteria:

          -  Inadequate samples

          -  Questionnaires with incomplete data

          -  Women who decided to leave the study
      

Gender

Female

Ages

15 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Hugo Mendieta Zerón, PhD., , 

NCT ID

NCT01924117

Organization ID

2902/2010UAEMéx

Responsible Party

Principal Investigator

Study Sponsor

Materno-Perinatal Hospital of the State of Mexico

Collaborators

 Universidad Autonoma del Estado de Mexico

Study Sponsor

Hugo Mendieta Zerón, PhD., Study Chair, Universidad Autónoma del Estado de México

Verification Date

August 2013