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Human Papillomavirus Infection and Virus Genotyping in Uterine Cervix Cancer in Venezuela (HPI)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Dr. Jorge Sanchez Lander, Instituto Oncologico Luis Razetti
ClinicalTrials.gov Identifier:
NCT00937547
First received: July 10, 2009
Last updated: November 30, 2012
Last verified: November 2012
  Purpose
  1. Hypothesis:

    If high risk genotypes of human papillomavirus (HPV) is the cause of cervical cancer worldwide, the genotypes associated with cervical cancer in Venezuela would be the same types found in other countries.

  2. Objectives:

Primary objective:

The objective of this investigation is to determine the presence and genotypes of HVP infection in cervical intraepithelial neoplasia grade 2/3 (CIN 2/3), and Stage I cervical epidermoid carcinoma and cervical adenocarcinoma.

Specific objectives:

To establish the presence of HPV in cervical cancer patients in Venezuela by geographic distribution.

To establish which HPV types are linked with cervical cancer in Venezuela by geographic distribution.


Condition
Cervical Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Observational Study for Determine the Presence and Genotypes of HVP Infection in Cervical Intraepithelial Neoplasia Grade II-III (CIN II-III), and Stage I Cervical Epidermoid Carcinoma and Cervical Adenocarcinoma.

Resource links provided by NLM:


Further study details as provided by Instituto Oncologico Luis Razetti:

Primary Outcome Measures:
  • HPV Identification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    HPV distribution was identified in CIN2, CIN3 and invasive cervical cancer

  • HPV Type 16 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of biopsies positive to HPV 16.

  • HPV Type 18 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of biopsies positive to HPV 18.

  • HPV Type 31 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of biopsies positive to HPV 31.

  • HPV Type 33 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of biopsies positive to HPV 33.

  • HPV Type 45 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of biopsies positive to HPV 45.

  • HPV Type 58 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of biopsies positive to HPV 58.

  • HPV Type 51 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of biopsies positive to HPV 51.


Biospecimen Retention:   Samples With DNA

4.1. Collection of cervical samples:

1. Previous ethics committe approval (Instituto Venezolano de Investigaciones Cientificas and Instituto de Oncología Luis Razetti), we are going to collect paraffin bloks of 300 patients with hystologic diagnosis of CIN 2/3 or Stage I cervical cancer.

The samples will be obtained from archives of the Pathology Units of the following medical centers in Venezuela: Instituto de Oncología Luis Razetti, Anatomía Patológica Universidad Central de Venezuela, Hospital Oncológico Pérez Carreño (Valencia), Maracaibo, Barquisimeto, Ciudad Bolívar, Puerto La Cruz, Mérida and Barinas.


Enrollment: 329
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:

In Venezuela, cervical cancer is the second leading cause of cancer mortality in women. In developed countries, although it is not the first cause of cancer mortality, occupies a remarkable place in the neoplastic pathology (Cannistra, 1996; Dey, 1998).

Human Papilloma Virus (HPV) is involved in the development of cervical cancer, specially oncogenic types 16 and 18 (Koskela, 2000; Markowska, 1999).

To date, it is still unknown which HPV types are more frequent in Venezuela. Several studies made in this country concluded that HPV 16 is the predominant type in cervical pathology (Graterol 2006, Correnti 1997, Muñoz 2003), but there has not been performed a HVP genotyping to detect all the types involved in patients with cervical cancer. Neither has been establish which HPV types are more frequently involved in genital warts in Venezuela.

The goal of this investigation is perform a genotypification of HPV in cervical cancer and cervical intraepithelial neoplasia 2 and 3 in Venezuela to determine which types are more frequently related to this disease in our country.

4. STUDY DESIGN:

4.1. Collection of cervical samples:

1. Previous ethics committee approval (Instituto Venezolano de Investigaciones Cientificas and Instituto de Oncología Luis Razetti), we are going to collect paraffin blocks of 300 patients with histological diagnosis of CIN 2-3 or Stage I cervical cancer.

The samples will be obtained from archives of the Pathology Units of the following medical centers in Venezuela: Instituto de Oncología Luis Razetti, Anatomía Patológica Universidad Central de Venezuela(Caracas), Hospital Oncológico Pérez Carreño (Valencia), Maracaibo, Barquisimeto, Ciudad Bolívar, Puerto La Cruz, Mérida and Barinas.

Inclusion criteria:

  1. Paraffin blocks with CIN 2/3, and Stage I cervical cancer biopsies obtained between 2001 and 2011.
  2. Properly blocks identification in order to obtain personal and clinical patient information.

4.2. Molecular biology procedures:

  1. Histologically handling of tissue: previous identification of pathologic lesions as described in inclusion criteria by an expert pathologist (sample with lesion but without necrosis), the paraffin block will be cut into 5 to 7 µm slides with new blades and gloves for each cut. It will be obtain 1 slides that will be distributed as follows: one sample will be send to Laboratorio de Virología Molecular del Instituto Venezolano de Investigaciones Científicas; the remained sample will be kept for further evaluation if is necessary. Each slide will be placed in a proper container and will be identified by a serial number in order to preserve patient intimacy and avoid biased results.
  2. Deparaffinisation as described in Coombs 1999.
  3. Tissue digestion, DNA extraction and precipitation as described in Gravitt 2000.
  4. HPV genotyping will be detected by INNOLiPA system. The results will be correlated with clinical information.
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

cervical samples

Criteria

Inclusion Criteria:

paraffin blocks of 329 patients with histologic diagnosis of CIN 2, CIN 3 or Stage I cervical cancer. -

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937547

Locations
Venezuela
Instituto Oncologico Luis razetti
Caracas, DF, Venezuela
Jorge Sanchez Lander
Caracas, Miranda, Venezuela, 1060
Sponsors and Collaborators
Instituto Oncologico Luis Razetti
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Jorge sanchez, MD Instituto Oncologico Luis Razetti
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Jorge Sanchez Lander, Dr. Jorge Sanchez-Lander, Instituto Oncologico Luis Razetti
ClinicalTrials.gov Identifier: NCT00937547     History of Changes
Other Study ID Numbers: CERVICAL CANCER AND HPV
Study First Received: July 10, 2009
Results First Received: June 6, 2012
Last Updated: November 30, 2012
Health Authority: Venezuela: Ministry of Health and Social Development

Keywords provided by Instituto Oncologico Luis Razetti:
cervical cancer
Human Papillomavirus Infection

Additional relevant MeSH terms:
Cervical Intraepithelial Neoplasia
Infection
Papillomavirus Infections
Uterine Cervical Neoplasms
Carcinoma
Carcinoma in Situ
DNA Virus Infections
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Tumor Virus Infections
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Virus Diseases

ClinicalTrials.gov processed this record on November 23, 2014