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

February 15, 2017 updated by: Xiang Gao, Sixth Affiliated Hospital, Sun Yat-sen University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Department of Gastroenterology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All consecutive female adult patients betwween 20-60 year old were recruited from July 2015 to July 2017. Female persons who performed physical examination in our hospital with the same age were recuited as control. All of the received HPV DNA testing and TCT. The case and control were matched 1:3

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case group
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
control group
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

What is the study measuring?

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.
Time Frame: 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.
July 2015 to July 2017
The different incidence of cervical neoplasm between controls and patients by performing Thinprep Cytology Test
Time Frame: 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.
July 2015 to July 2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Find drugs relating to HPV infection of IBD patients
Time Frame: 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.
July 2015 to July 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Study Director: Xiang Gao, PhD, The sixth affiated hospital of Sun-Yat sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 15, 2017

First Posted (ACTUAL)

February 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 15, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHBY-YJFA-20160813

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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