HPV Infection and Cervical Neoplasm in Women With Inflammatory Bowel Disease: a Cross-sectional Study

Study Overview
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Brief Summary
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The associations between female inflammatory bowel disease (IBD) patients and human papilloma virus (HPV) infection and cervical neoplasia (dysplasia or cancer) were unclear. Especially there was no data for Chinese IBD population. So we investigated the incidence and risk factors of HPV infection and cervical neoplasia (dysplasia or cancer) in female IBD patient.

Official Title
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HPV Infection and Cervical Neoplasm in Women With Inflammatory Bowel Disease: a Cross-sectional Study

Conditions
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HPV-Related Cervical Carcinoma, Inflammatory Bowel Diseases, Cervical Neoplasm

Intervention / Treatment
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* Other: Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologist


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 20-60 years old; Patients diagnosed as IBD according to previously established international criteria Exclusion Criteria: 1. Patients refuse to participating

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case group<br>Female IBD patients who had sexual life between 21-60 years-old were recruited. | Other: Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologist<br> <br> |
| control group<br>Female people who perform physical examination in our hospital between 21-60 years-old were recruited as control during the study period. | Other: Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologist<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The different infection rate of HPV between controls and patients by detecting HPV-DNA using reverse dot-blot method. | The difference of infection rate of HPV between healthy control and IBD patients was not clear.We are detecting HPV-DNA by reverse dot-blot and calculate the positive rate of HPV infection among controls and patients. | July 2015 to July 2017 | 
| The different incidence of cervical neoplasm between controls and patients by performing Thinprep Cytology Test | The difference of the incidence of cervical neoplasm between healthy control and IBD patients was not clear.All the controls and patients are going to perform Thinprep Cytology Test which could detect intraepithelial neoplasia of cervix. | July 2015 to July 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Find drugs relating to HPV infection of IBD patients | Most IBD patients used steroid, infliximab or immunosuppressant to manage the disease. We separate patients into two groups according to using a certain drug or not. Then we compare the HPV infection rate between the two groups by Pearson-X2 test using SPSS 13.0 software (SPSS Inc., Chicago, Ill., USA).P < 0.05 was considered statistically significant. | July 2015 to July 2017 |