HPV Infection and Cervical Neoplasm in Women With Inflammatory Bowel Disease: a Cross-sectional Study
1 other identifier
observational
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 8, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedFebruary 16, 2017
February 1, 2017
1.8 years
February 8, 2017
February 15, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Find drugs relating to HPV infection of IBD patients
July 2015 to July 2017
Study Arms (2)
Case group
Female IBD patients who had sexual life between 21-60 years-old were recruited.
control group
Female people who perform physical examination in our hospital between 21-60 years-old were recruited as control during the study period.
Interventions
Eligibility Criteria
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
You may qualify if:
- between 20-60 years old;
- Patients diagnosed as IBD according to previously established international criteria
You may not qualify if:
- \. Patients refuse to participating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Gastroenterology
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xiang Gao, PhD
The sixth affiated hospital of Sun-Yat sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Week
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 8, 2017
First Posted
February 16, 2017
Study Start
July 1, 2015
Primary Completion
May 1, 2017
Study Completion
July 1, 2017
Last Updated
February 16, 2017
Record last verified: 2017-02