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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03055130

Enrollment

160

Registered

2017-02-16

Start date

2015-07-31

Completion date

2017-07-31

Last updated

2017-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERThinprep Cytology Test (TCT) and HPV infection types were tested by gynecologist

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactQingfan Yang, MD

helengao818@163.com+860203866343

Backup ContactXiang Gao, PhD