Human Papilloma VirusNCT04397081
Atopic Diseases & Human Papilloma Virus
An observational study of Human Papilloma Virus and Atopic Asthma, run by Adana Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus, Atopic Asthma, Atopic Disorders
- What is being tested?
- HPV test results
- How many people
- 239 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2019to 30 Mar 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Pregnant women
- women who receive immunosuppressive therapy (including chemotherapy and chronic corticosteroid therapy)
- HIV positive women
- women with cancer
- women performed hysterectomy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana City Education and Research Hospital
Adana, Merkez, 01100
About this study
Official title: Comparison of Human Papilloma Virus Results in Women With and Without Atopic Disease
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.
Read the 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.
- Conditions
- Human Papilloma Virus, Atopic Asthma, Atopic Disorders
- Being tested
- HPV test results
- Keywords
- Human papilloma virus,, screening test,, atopic diseases,, asthma,, rhinitis,, urticaria
- Medical subject headings
- Asthma, Rhinitis, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV test resultsOther
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 | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: HPV test results |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Aug 2019
- Primary completion29 Feb 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Adana Numune Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gulsum Uysal, Adana Numune Training and Research Hospital
- Investigators
- Gulsum Uysal, Principal investigator, Adana City Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397081
- Sponsor's protocol ID
- 494/2019
- Status last verified
- May 2020
- First submitted
- 17 May 2020
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Human Papilloma Virus Results in Women With and Without Atopic Disease
- ClinicalTrials.gov ID
- NCT04397081
- Acronym / sponsor ID
- 494/2019
- Conditions
- Human Papilloma Virus, Atopic Asthma, Atopic Disorders
- Keywords
- Human papilloma virus,, screening test,, atopic diseases,, asthma,, rhinitis,, urticaria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Adana Numune Training and Research HospitalOther government
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: HPV test resultsControl 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. |
| Study group | – | Other: HPV test resultsStudy 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnant women
- women who receive immunosuppressive therapy (including chemotherapy and chronic corticosteroid therapy)
- HIV positive women
- women with cancer
- women performed hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV test resultsThe 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. | Other | Control Group, Study group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2020.
- Individual participant dataSharing planned: No
Related trials for Human Papilloma Virus
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
Active, not recruiting
HPV Multilevel Intervention Strategies Targeting Immunization in Community Settings (HPV MISTICS)
Human Papilloma Virus (HPV) Vaccine
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
Active, not recruitingPhase 3
Cantharidin Application in Patients With Common Warts (Verruca Vulgaris) (COVE-2)
Common Warts, Common Warts (Verruca Vulgaris)
RecruitingPhase 3
Long-Term Follow-up Study of Cantharidin (YCANTH [VP-102/TO-208]) in Patients With Common Warts (Verruca Vulgaris)
Common Warts (Verruca Vulgaris), Common Warts
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulsum Uysal principal investigator
Adana City Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papilloma Virus and Atopic Asthma, run by Adana Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare HPV screening results between women diagnosed with atopic disease and healthy women without a history of atopy. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2020; AzTrials last refreshed its copy on 6 Nov 2026.