NCT04397081

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
Last Updated

May 26, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

May 17, 2020

Last Update Submit

May 21, 2020

Conditions

Keywords

Human papilloma virus,screening test,atopic diseases,asthma,rhinitis,urticaria

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

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.

Control GroupStudy group

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana City Education and Research Hospital

Adana, Merkez, 01100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AsthmaRhinitisUrticaria

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfectionsNose DiseasesOtorhinolaryngologic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Gulsum Uysal

    Adana City Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Obstetrics and Gynecology Department

Study Record Dates

First Submitted

May 17, 2020

First Posted

May 21, 2020

Study Start

August 1, 2019

Primary Completion

February 29, 2020

Study Completion

March 30, 2020

Last Updated

May 26, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations