Atopic Diseases & Human Papilloma Virus

Human Papilloma Virus Clinical Trial

Official title:

Comparison of Human Papilloma Virus Results in Women With and Without Atopic Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04397081
• Other study ID #: 494/2019
• Status: Completed
• Start date: August 1, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: May 2020
• Source: Adana Numune Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: March 30, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Asthma
• Atopic Disorders
• Human Papilloma Virus
• Papilloma

Intervention

Other:
• HPV test results
The human papillomavirus (HPV) test detects the presence of the human papillomavirus, a virus that can lead to the development of genital warts, abnormal cervical cells or cervical cancer. The procedure includes taking samples of your cervical cells using a soft brush and a flat scraping device called a spatula. This doesn't hurt, and you may not even feel the sample being taken.

Locations

Country	Name	City	State
Turkey	Adana City Education and Research Hospital	Adana	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Adana Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to compare HPV screening results between women diagnosed with atopic disease and healthy women without a history of atopy.	comparing HPV test results between groups.	6 months