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

Sponsor
Instituto Oncologico Luis Razetti (Other)
Overall Status
Completed
CT.gov ID
NCT00937547
Collaborator
Merck Sharp & Dohme LLC (Industry)
329
Enrollment
2
Locations
19.9
Duration (Months)
164.5
Patients Per Site
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  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.

  1. 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 or Disease Intervention/Treatment Phase

    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.

    1. 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    329 participants
    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.
    Study Start Date :
    Nov 1, 2009
    Actual Primary Completion Date :
    Jul 1, 2011
    Actual Study Completion Date :
    Jul 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. HPV Identification [6 months]

      HPV distribution was identified in CIN2, CIN3 and invasive cervical cancer

    2. HPV Type 16 [6 months]

      Number of biopsies positive to HPV 16.

    3. HPV Type 18 [6 months]

      Number of biopsies positive to HPV 18.

    4. HPV Type 31 [6 months]

      Number of biopsies positive to HPV 31.

    5. HPV Type 33 [6 months]

      Number of biopsies positive to HPV 33.

    6. HPV Type 45 [6 months]

      Number of biopsies positive to HPV 45.

    7. HPV Type 58 [6 months]

      Number of biopsies positive to HPV 58.

    8. HPV Type 51 [6 months]

      Number of biopsies positive to HPV 51.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Instituto Oncologico Luis razetti Caracas DF Venezuela
    2 Jorge Sanchez Lander Caracas Miranda Venezuela 1060

    Sponsors and Collaborators

    • Instituto Oncologico Luis Razetti
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Jorge sanchez, MD, Instituto Oncologico Luis Razetti

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Dr. Jorge Sanchez Lander, Dr. Jorge Sanchez-Lander, Instituto Oncologico Luis Razetti
    ClinicalTrials.gov Identifier:
    NCT00937547
    Other Study ID Numbers:
    • CERVICAL CANCER AND HPV
    First Posted:
    Jul 13, 2009
    Last Update Posted:
    Dec 4, 2012
    Last Verified:
    Nov 1, 2012
    Keywords provided by Dr. Jorge Sanchez Lander, Dr. Jorge Sanchez-Lander, Instituto Oncologico Luis Razetti
    cervical cancer
    Human Papillomavirus Infection
    Additional relevant MeSH terms:
    Infections
    Papillomavirus Infections
    Uterine Cervical Neoplasms

    Study Results

    Participant Flow

    Recruitment Details Samples were collected from files between 2001-2011
    Pre-assignment Detail 14 samples were excluded because of misdiagnosis.
    Arm/Group Title Invasive Cervical Cancer Cervical Intraepithelial Neoplasia 2 Cervical Intraepithelial Neoplasia 3
    Arm/Group Description patients with histologic diagnosis invasive cervical cancer. patients with histological diagnosis of cervical intraepithelial neoplasia grade 2 patients with histological diagnosis of cervical intraepithelial neoplasia grade 3
    Period Title: Overall Study
    STARTED 96 84 149
    Histological Samples 95 78 142
    COMPLETED 95 78 142
    NOT COMPLETED 1 6 7

    Baseline Characteristics

    Arm/Group Title Invasive Cervical Cancer Intraepithelial Cervical Neoplasia 3 Intraepithelial Cervical Neoplasia 2 Total
    Arm/Group Description Paraffin-embedded samples with histological diagnosis of invasive cervical cancer Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 3 Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 2 Total of all reporting groups
    Overall Participants 96 149 84 329
    Age (Count of Participants)
    <=18 years
    2
    2.1%
    1
    0.7%
    1
    1.2%
    4
    1.2%
    Between 18 and 65 years
    90
    93.8%
    146
    98%
    81
    96.4%
    317
    96.4%
    >=65 years
    4
    4.2%
    2
    1.3%
    2
    2.4%
    8
    2.4%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    44.5
    (12.04)
    37.6
    (10.42)
    36.9
    (9.34)
    39.27
    (11.12)
    Sex: Female, Male (Count of Participants)
    Female
    96
    100%
    149
    100%
    84
    100%
    329
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    Venezuela
    96
    100%
    149
    100%
    84
    100%
    329
    100%

    Outcome Measures

    1. Primary Outcome
    Title HPV Identification
    Description HPV distribution was identified in CIN2, CIN3 and invasive cervical cancer
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Invasive Cervical Cancer Cervical Intraepithelial Neoplasia 3 Cervical Intraepithelial Neoplasia 2
    Arm/Group Description Paraffin-embedded sample with histological diagnosis of invasive cervical cancer Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3 Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
    Measure Participants 96 149 84
    Number [biopsies]
    95
    142
    78
    2. Primary Outcome
    Title HPV Type 16
    Description Number of biopsies positive to HPV 16.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Invasive Cervical Cancer Cervical Intraepithelial Neoplasia 3 Cervical Intraepithelial Neoplasia 2
    Arm/Group Description Paraffin-embedded sample with histological diagnosis of invasive cervical cancer Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3 Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
    Measure Participants 95 142 78
    Number [biopsies]
    65
    90
    35
    3. Primary Outcome
    Title HPV Type 18
    Description Number of biopsies positive to HPV 18.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Invasive Cervical Cancer Cervical Intraepithelial Neoplasia 3 Cervical Intraepithelial Neoplasia 2
    Arm/Group Description Paraffin-embedded sample with histological diagnosis of invasive cervical cancer Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3 Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
    Measure Participants 95 142 78
    Number [biopsies]
    11
    14
    5
    4. Primary Outcome
    Title HPV Type 31
    Description Number of biopsies positive to HPV 31.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Invasive Cervical Cancer Cervical Intraepithelial Neoplasia 3 Cervical Intraepithelial Neoplasia 2
    Arm/Group Description Paraffin-embedded sample with histological diagnosis of invasive cervical cancer Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3 Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
    Measure Participants 95 142 78
    Number [biopsies]
    6
    10
    8
    5. Primary Outcome
    Title HPV Type 33
    Description Number of biopsies positive to HPV 33.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Invasive Cervical Cancer Cervical Intraepithelial Neoplasia 3 Cervical Intraepithelial Neoplasia 2
    Arm/Group Description Paraffin-embedded sample with histological diagnosis of invasive cervical cancer Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3 Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
    Measure Participants 95 142 78
    Number [biopsies]
    6
    10
    5
    6. Primary Outcome
    Title HPV Type 45
    Description Number of biopsies positive to HPV 45.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Invasive Cervical Cancer Cervical Intraepithelial Neoplasia 3 Cervical Intraepithelial Neoplasia 2
    Arm/Group Description Paraffin-embedded sample with histological diagnosis of invasive cervical cancer Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3 Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
    Measure Participants 95 142 78
    Number [biopsies]
    6
    6
    5
    7. Primary Outcome
    Title HPV Type 58
    Description Number of biopsies positive to HPV 58.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Invasive Cervical Cancer Cervical Intraepithelial Neoplasia 3 Cervical Intraepithelial Neoplasia 2
    Arm/Group Description Paraffin-embedded sample with histological diagnosis of invasive cervical cancer Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3 Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
    Measure Participants 95 142 78
    Number [biopsies]
    3
    7
    5
    8. Primary Outcome
    Title HPV Type 51
    Description Number of biopsies positive to HPV 51.
    Time Frame 6 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Invasive Cervical Cancer Cervical Intraepithelial Neoplasia 3 Cervical Intraepithelial Neoplasia 2
    Arm/Group Description Paraffin-embedded sample with histological diagnosis of invasive cervical cancer Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3 Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
    Measure Participants 95 142 78
    Number [biopsies]
    1
    5
    7

    Adverse Events

    Time Frame
    Adverse Event Reporting Description No adverse event assessment because there were no patient intervention, there were used biopsies from archives for the analysis.
    Arm/Group Title Invasive Cervical Cancer Intraepithelial Cervical Neoplasia 3 Intraepithelial Cervical Neoplasia 2
    Arm/Group Description Paraffin-embedded samples with histological diagnosis of invasive cervical cancer Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 3 Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 2
    All Cause Mortality
    Invasive Cervical Cancer Intraepithelial Cervical Neoplasia 3 Intraepithelial Cervical Neoplasia 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Invasive Cervical Cancer Intraepithelial Cervical Neoplasia 3 Intraepithelial Cervical Neoplasia 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Invasive Cervical Cancer Intraepithelial Cervical Neoplasia 3 Intraepithelial Cervical Neoplasia 2
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN) 0/0 (NaN)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Jorge Sánchez-Lander Corresponding Author
    Organization Instituto de Oncología Dr. Luis Razetti, Caracas Venezuela
    Phone 582129870165
    Email animamotrix@live.com
    Responsible Party:
    Dr. Jorge Sanchez Lander, Dr. Jorge Sanchez-Lander, Instituto Oncologico Luis Razetti
    ClinicalTrials.gov Identifier:
    NCT00937547
    Other Study ID Numbers:
    • CERVICAL CANCER AND HPV
    First Posted:
    Jul 13, 2009
    Last Update Posted:
    Dec 4, 2012
    Last Verified:
    Nov 1, 2012