Genotypification and Predisposing Factors in Human Papilloma Virus Infection

Intraepithelial Neoplasia Clinical Trial

— HPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924117
• Other study ID #: 2902/2010UAEMéx
• Status: Completed
• Phase: N/A
• First received: August 13, 2013
• Last updated: August 15, 2013
• Start date: February 2011
• Est. completion date: October 2011

Study information

• Verified date: August 2013
• Source: Materno-Perinatal Hospital of the State of Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: October 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Intraepithelial Neoplasia
• Papillomavirus Infections
• Virus Diseases

Intervention

Other:
• Linear Array HPV Genotyping assay
All samples with the suspicion of squamous intraepithelial lesion were processed with the Linnear Array methodology to identify HPV genotypes

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Materno-Perinatal Hospital of the State of Mexico	Universidad Autonoma del Estado de Mexico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multiple HPV infection	While women are revised by colposcopy the Gynecologist will refer them to a cervical swab for DNA extraction in case of suspicious of HPV infection.	At the moment of the colposcopy	No
Secondary	squamous intraepithelial lesions	The pathologist will determine the presence or absence of SIL with the sample taken in the Papanicolaou smear appointment	Within one week after the cervical sample taken by the technician	No