Genotypification and Predisposing Factors in Human Papilloma Virus Infection

NCT01924117 | Completed

• 1 other identifier: 2902/2010UAEMéx
• Study Type: interventional
• Target: 129
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Intraepithelial Neoplasia

Keywords

cervical intraepithelial neoplasia, HPV, Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• squamous intraepithelial lesions

  Within one week after the cervical sample taken by the technician

Study Arms (1)

Linear Array HPV Genotyping assay

NO INTERVENTION

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).

Other: Linear Array HPV Genotyping assay

Interventions

Linear Array HPV Genotyping assay OTHER

All samples with the suspicion of squamous intraepithelial lesion were processed with the Linnear Array methodology to identify HPV genotypes

Also known as: Linnear Array methodology

Linear Array HPV Genotyping assay

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Inadequate samples
• Questionnaires with incomplete data
• Women who decided to leave the study

Sponsors & Collaborators

• Materno-Perinatal Hospital of the State of Mexico: lead
• Universidad Autonoma del Estado de Mexico: collaborator

MeSH Terms

Conditions

Carcinoma in Situ; Uterine Cervical Dysplasia; Papillomavirus Infections; Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Precancerous Conditions; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hugo Mendieta Zerón, PhD.

  Universidad Autónoma del Estado de México

  STUDY CHAIR

• María del Carmen Colín Ferreyra, MSc.

  Universidad Autónoma del Estado de México

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 16, 2013
• Study Start: February 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 16, 2013

Record last verified: 2013-08