Clinical trial NCT04397081: Atopic Diseases & Human Papilloma Virus
Official title: Comparison of Human Papilloma Virus Results in Women With and Without Atopic Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papilloma Virus
Atopic Asthma
Atopic Disorders
Keywords: Human papilloma virus,
screening test,
atopic diseases,
asthma,
rhinitis,
urticaria
Lead sponsor: Adana Numune Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-21
Enrollment: 239
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between the ages of 30-65 with allergic complaints (sneezing, itching,runy nose, respiratory distress) were diagnosed "atopic disease" (allergic asthma, allergic rhinitis, allergic conjunctivitis, chronic urticaria and atopic dermatitis) by same clinician in Immunology and Allergy Department. Healthy women without allergic complaints applied for routine gynecologic examination occurred control group.

Brief summary: Cervical cancer is an important health problem in women. Human papillomavirus (HPV) is considered the primary etiological agent of cervical cancer worldwide. Cervical cancer screening methods are proved one of the few screening methods that are thought to decrease invasive cancer incidence and mortality. In our country, HPV screening is carried out free of charge by public health to women between the ages of 30-65 aim is to compare HPV screening results between women diagnosed with atopic disease and healthy women without a history of atopy.If HPV is detected more frequently in patients with atopy, it may be recommended to follow more closely in vaccination and screening programs. Therefore, our study was designed to evaluate whether HPV positivity is common in atopic women.

Detailed description: Patients between the ages of 30-65 with allergic complaints (sneezing, itching,runy nose, respiratory distress) were diagnosed "atopic disease" (allergic asthma, allergic rhinitis, allergic conjunctivitis, chronic urticaria and atopic dermatitis) by same clinician in Immunology and Allergy Department. Women aged between 30-65 years are scanned free of charge (HPV and smears) by the Public Health Institution in our country. The HPV results of the screened patients were noted retrospectively through the result reports of the patients, and those who were not screened were directed to Gynecology Department and HPV results were followed. Healthy women without allergic complaints applied for routine gynecologic examination occurred control group. Similarly, the HPV results of the control group were recorded.

Pregnant women, women who receive immunosuppressive therapy (including chemotherapy and chronic corticosteroid therapy), HIV positive women, women with cancer and performed hysterectomy were excluded. Patients' height, weight, demographic features (age, marital status, income level), obstetric histories (gravida, parity, mode of delivery), contraception methods and smoking status were noted.

Subgroup atopic disease diagnoses, duration of illness, treatments regimes and treatment time of the patients in the study group were also questioned and recorded. Leukotriene receptor antagonists and histamine receptor antagonists were the main treatments for study group and all therapies were designed by the same clinician. Routine allergic skin tests were performed to all atopic patients during diagnosis.

Statistical analyses

Statistical Package for Social Sciences (SPSS) for Windows, version 18.0 (SPSS Inc., USA) was used to compare the clinical features of groups. Normality of data distribution was tested with Kolmogorov-Smirnov test. Data was shown as means ± standart deviation (SD) for continuous variables and the independent t test was used to assess the differences in variables between groups. Kruskal-Wallis, Mann-Whitney U-test and Bonferroni correction were used for values with non-normal distribution. P Values below 0.05 (p\<0.05) was accepted as statistically significant.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 30-65 with allergic complaints (sneezing, itching,runy nose, respiratory distress) diagnosed "atopic disease" (allergic asthma, allergic rhinitis, allergic conjunctivitis, chronic urticaria and atopic dermatitis) by same clinician in Immunology and Allergy Department.
* Patients between the ages of 30-65 without allergic complaints

Exclusion Criteria:

* Pregnant women
* women who receive immunosuppressive therapy (including chemotherapy and chronic corticosteroid therapy)
* HIV positive women
* women with cancer
* women performed hysterectomy

Primary outcomes:
measure: to compare HPV screening results between women diagnosed with atopic disease and healthy women without a history of atopy.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana City Education and Research Hospital
state: Merkez
Study officials:
affiliation: Adana City Education and Research Hospital
name: Gulsum Uysal
role: PRINCIPAL_INVESTIGATOR
References: