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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03055130
Other study ID # HHBY-YJFA-20160813
Secondary ID
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
Health authority
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

Study Design


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
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