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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03055130
• Other study ID #: HHBY-YJFA-20160813
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2017
• Last updated: February 15, 2017
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: February 2017
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Qingfan Yang, MD
• Phone: +860203866343
• Email: helengao818[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Neoplasm
• HPV-Related Cervical Carcinoma
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Neoplasms
• Uterine Cervical Neoplasms

Intervention

Other:
• Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologist

Locations

Country	Name	City	State
China	Department of Gastroenterology	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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