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Atopic Diseases & Human Papilloma Virus

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ClinicalTrials.gov Identifier: NCT04397081
Recruitment Status : Completed
First Posted : May 21, 2020
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Gulsum Uysal, Adana Numune Training and Research Hospital

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.

Condition or disease Intervention/treatment
Human Papilloma Virus Atopic Asthma Atopic Disorders Other: HPV test results

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 239 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Comparison of Human Papilloma Virus Results in Women With and Without Atopic Disease
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : February 29, 2020
Actual Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control Group
Control group was defined as healthy patients between the ages of 30-65 without allergic complaints.Patients' height, weight, demographic features (age, marital status, income level), obstetric histories (gravida, parity, mode of delivery), contraception methods and smoking status were noted.
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.

Study group

Study group was defined as patients between the ages of 30-65 with allergic complaints 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. 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.

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.




Primary Outcome Measures :
  1. to compare HPV screening results between women diagnosed with atopic disease and healthy women without a history of atopy. [ Time Frame: 6 months ]
    comparing HPV test results between groups.



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397081


Locations
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Turkey
Adana City Education and Research Hospital
Adana, Merkez, Turkey, 01100
Sponsors and Collaborators
Adana Numune Training and Research Hospital
Investigators
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Principal Investigator: Gulsum Uysal Adana City Education and Research Hospital
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Responsible Party: Gulsum Uysal, Associate Professor in Obstetrics and Gynecology Department, Adana Numune Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04397081    
Other Study ID Numbers: 494/2019
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gulsum Uysal, Adana Numune Training and Research Hospital:
Human papilloma virus,
screening test,
atopic diseases,
asthma,
rhinitis,
urticaria
Additional relevant MeSH terms:
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Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms