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
About this trial
This is an interventional diagnostic trial for ASC-US focused on measuring ASCUS, HPV, Vitamine B12, Folate
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
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
NCT ID
NCT03903952
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
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
Learn more about this trial
Can B12 and Folate Levels Predict HPV Penetration in Patients With ASCUS?
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