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

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.

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Key information

Conditions

ASC-US Atypical Squamous Cells of the Cervix Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Human Papilloma Virus Morphological and Microscopic Findings Neoplasms Pathological Conditions, Signs and Symptoms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin B12 and folate

Dietary Supplement

Vitamin B12 and folate levels in blood

Primary outcomes

the vitamine B12 levels .

Time frame: 1 year

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

Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Other

Collaborators

Sisli Hamidiye Etfal Training and Research Hospital

Registry information

Official study title

Serum Levels of Folate And Vitamine B12 in Patients Infected With HPV and Diagnosed Atypical Squamous Cells of Undetermined Significance in Cervical Cytology

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Apr 4, 2019
Registry last updated: Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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