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Can B12 and Folate Levels Predict HPV Penetration in Patients With ASCUS?

Primary Purpose

ASC-US, Human Papilloma Virus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin B12 and folate
Sponsored by
Sanliurfa Mehmet Akif Inan Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ASC-US focused on measuring ASCUS, HPV, Vitamine B12, Folate

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • female patients aged between 30-65 who were undergoing smear tests with the aim of control
  • body mass index (BMI) lower than 35
  • Participants did not have any chronic diseases

Exclusion Criteria:

  • Patients taking B12 and folate supplement due to mix type anemia
  • patients taking active vitamin B12 and folate-containing vitamin supplements
  • pregnant women
  • women with other cervical intraepithelial lesions such as low grade squamous intraepithelial lesion (LGSIL), high grade squamous intraepithelial lesion (HGSIL) or high grade squamous intraepithelial lesion can not be excluded (ASC-H) in smear
  • patients with cervical cancer diagnosis
  • patients who were operated due to cervical cancer
  • patients who had HPV vaccine
  • patients with a diagnosis that can inhibit B12 and folate absorption in gastro-intestinal tract
  • vegetarians

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Papanicolaou smear result (control group)

    Papanicolaou smear result (study group)

    Arm Description

    women who did not have intraepithelial neoplasia as a result of smear

    women who have atypical squamous cells of undetermined significance (ASCUS) as a result of smear

    Outcomes

    Primary Outcome Measures

    the vitamine B12 levels .
    the vitamine B12 levels in patients with ASCUS (+) smear.
    The folate levels
    the folate levels in patients with ASCUS (+) smear.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 1, 2019
    Last Updated
    April 3, 2019
    Sponsor
    Sanliurfa Mehmet Akif Inan Education and Research Hospital
    Collaborators
    Sisli Hamidiye Etfal Training and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03903952
    Brief Title
    Can B12 and Folate Levels Predict HPV Penetration in Patients With ASCUS?
    Official Title
    Serum Levels of Folate And Vitamine B12 in Patients Infected With HPV and Diagnosed Atypical Squamous Cells of Undetermined Significance in Cervical Cytology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2014 (Actual)
    Primary Completion Date
    May 30, 2015 (Actual)
    Study Completion Date
    May 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sanliurfa Mehmet Akif Inan Education and Research Hospital
    Collaborators
    Sisli Hamidiye Etfal Training and Research Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Non-classified atypical squamous cells (ASCUS) is the most common abnormal cervical cytology (%39). The risk of cervical intraepithelial neoplasia 2-3 is 5% and the risk of carcinoma is around 0.1% after diagnosis. Mostly human papillomavirus (HPV) is responsible for this transition. Most of them are transient, but some infections become persistent and can progress into precancer and invasive cancer. In the process of progression to cancer; patients with cell cycle problems are thought to be at risk. In some studies, B12 and folate deficiency, which play a role in DNA synthesis and repair, have been shown to induce incorrect binding of uracil to DNA, leading to DNA breakage and repair disorder. Therefore, in this study, it has been aimed that the relation of presence of atypical squamous cells and HPV persistence with folate and vitamin B12 levels which effect on immune system.
    Detailed Description
    Participants were divided into two groups according to their smear results; atypical squamous cells of undetermined significance (ASCUS) (study group: 100 patients) and women who did not have intraepithelial neoplasia as a result of smear (control group: 100 patients). Patients who had well preserved sufficient number of squamous epithelial cells, who did not have bleeding, fixation failure, inflammation or atrophy, and had negative cervical cytology smear were considered as control group. HPV test was also requested from the study group. B12 and folate blood levels were compared between the groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ASC-US, Human Papilloma Virus
    Keywords
    ASCUS, HPV, Vitamine B12, Folate

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    200 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Papanicolaou smear result (control group)
    Arm Type
    Other
    Arm Description
    women who did not have intraepithelial neoplasia as a result of smear
    Arm Title
    Papanicolaou smear result (study group)
    Arm Type
    Other
    Arm Description
    women who have atypical squamous cells of undetermined significance (ASCUS) as a result of smear
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Vitamin B12 and folate
    Intervention Description
    Vitamin B12 and folate levels in blood
    Primary Outcome Measure Information:
    Title
    the vitamine B12 levels .
    Description
    the vitamine B12 levels in patients with ASCUS (+) smear.
    Time Frame
    1 year
    Title
    The folate levels
    Description
    the folate levels in patients with ASCUS (+) smear.
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: female patients aged between 30-65 who were undergoing smear tests with the aim of control body mass index (BMI) lower than 35 Participants did not have any chronic diseases Exclusion Criteria: Patients taking B12 and folate supplement due to mix type anemia patients taking active vitamin B12 and folate-containing vitamin supplements pregnant women women with other cervical intraepithelial lesions such as low grade squamous intraepithelial lesion (LGSIL), high grade squamous intraepithelial lesion (HGSIL) or high grade squamous intraepithelial lesion can not be excluded (ASC-H) in smear patients with cervical cancer diagnosis patients who were operated due to cervical cancer patients who had HPV vaccine patients with a diagnosis that can inhibit B12 and folate absorption in gastro-intestinal tract vegetarians

    12. IPD Sharing Statement

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    Can B12 and Folate Levels Predict HPV Penetration in Patients With ASCUS?

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