Human Papillomavirus Infection and Virus Genotyping in Uterine Cervix Cancer in Venezuela (HPI)
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|ClinicalTrials.gov Identifier: NCT00937547|
Recruitment Status : Completed
First Posted : July 13, 2009
Results First Posted : November 8, 2012
Last Update Posted : December 4, 2012
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.
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.
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 or disease|
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.
- Paraffin blocks with CIN 2/3, and Stage I cervical cancer biopsies obtained between 2001 and 2011.
- Properly blocks identification in order to obtain personal and clinical patient information.
4.2. Molecular biology procedures:
- 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.
- Deparaffinisation as described in Coombs 1999.
- Tissue digestion, DNA extraction and precipitation as described in Gravitt 2000.
- HPV genotyping will be detected by INNOLiPA system. The results will be correlated with clinical information.
|Study Type :||Observational|
|Actual Enrollment :||329 participants|
|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.|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
- HPV Identification [ Time Frame: 6 months ]HPV distribution was identified in CIN2, CIN3 and invasive cervical cancer
- HPV Type 16 [ Time Frame: 6 months ]Number of biopsies positive to HPV 16.
- HPV Type 18 [ Time Frame: 6 months ]Number of biopsies positive to HPV 18.
- HPV Type 31 [ Time Frame: 6 months ]Number of biopsies positive to HPV 31.
- HPV Type 33 [ Time Frame: 6 months ]Number of biopsies positive to HPV 33.
- HPV Type 45 [ Time Frame: 6 months ]Number of biopsies positive to HPV 45.
- HPV Type 58 [ Time Frame: 6 months ]Number of biopsies positive to HPV 58.
- HPV Type 51 [ Time Frame: 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00937547
|Instituto Oncologico Luis razetti|
|Caracas, DF, Venezuela|
|Jorge Sanchez Lander|
|Caracas, Miranda, Venezuela, 1060|
|Principal Investigator:||Jorge sanchez, MD||Instituto Oncologico Luis Razetti|