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

• Conditions: Inflammatory Bowel Diseases; HPV-Related Cervical Carcinoma; Cervical Neoplasm
• Interventions: Other: Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologist

• Registration Number: NCT03055130
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Status Verified: 2017-02
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-15
• Last Update Submitted: 2017-02-15
• Study First Posted: 2017-02-16
• Last Update Posted: 2017-02-16
• Primary Completion: 2017-05
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

1. between 20-60 years old;
2. Patients diagnosed as IBD according to previously established international criteria

Exclusion Criteria

1. Patients refuse to participating

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The different incidence of cervical neoplasm between controls and patients by performing Thinprep Cytology Test	July 2015 to July 2017	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.
The different infection rate of HPV between controls and patients by detecting HPV-DNA using reverse dot-blot method.	July 2015 to July 2017	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.

Secondary Outcome Measures

Name	Time	Method
Find drugs relating to HPV infection of IBD patients	July 2015 to July 2017	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.

Trial Locations

Locations (1)

Department of Gastroenterology; 🇨🇳 Guangzhou, Guangdong, China