- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03903952
Can B12 and Folate Levels Predict HPV Penetration in Patients With ASCUS?
April 3, 2019 updated by: Nefise Nazlı YENIGUL, Sanliurfa Mehmet Akif Inan Education and Research Hospital
Serum Levels of Folate And Vitamine B12 in Patients Infected With HPV and Diagnosed Atypical Squamous Cells of Undetermined Significance in Cervical Cytology
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Papanicolaou smear result (control group)
women who did not have intraepithelial neoplasia as a result of smear
|
Vitamin B12 and folate levels in blood
|
Other: Papanicolaou smear result (study group)
women who have atypical squamous cells of undetermined significance (ASCUS) as a result of smear
|
Vitamin B12 and folate levels in blood
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the vitamine B12 levels .
Time Frame: 1 year
|
the vitamine B12 levels in patients with ASCUS (+) smear.
|
1 year
|
The folate levels
Time Frame: 1 year
|
the folate levels in patients with ASCUS (+) smear.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2014
Primary Completion (Actual)
May 30, 2015
Study Completion (Actual)
May 30, 2015
Study Registration Dates
First Submitted
April 1, 2019
First Submitted That Met QC Criteria
April 3, 2019
First Posted (Actual)
April 4, 2019
Study Record Updates
Last Update Posted (Actual)
April 5, 2019
Last Update Submitted That Met QC Criteria
April 3, 2019
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 714
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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