Clinical trial NCT01924117: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraepithelial Neoplasia
Keywords: cervical intraepithelial neoplasia, HPV, Cancer
Lead sponsor: Materno-Perinatal Hospital of the State of Mexico
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma del Estado de Mexico
First posted: 2013-08-16
Enrollment: 129
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Multiple HPV infection
timeFrame: At the moment of the colposcopy
Secondary outcomes:
measure: squamous intraepithelial lesions
timeFrame: Within one week after the cervical sample taken by the technician
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Autónoma del Estado de México
name: Hugo Mendieta Zerón, PhD.
role: STUDY_CHAIR
affiliation: Universidad Autónoma del Estado de México
name: María del Carmen Colín Ferreyra, MSc.
role: PRINCIPAL_INVESTIGATOR
References: