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

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ClinicalTrials.gov Identifier: NCT03055130
Recruitment Status : Unknown
Verified February 2017 by Xiang Gao, Sixth Affiliated Hospital, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Xiang Gao, Sixth Affiliated Hospital, Sun Yat-sen University

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.

Condition or disease Intervention/treatment
HPV-Related Cervical Carcinoma Inflammatory Bowel Diseases Cervical Neoplasm Other: Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologist

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Week
Official Title: HPV Infection and Cervical Neoplasm in Women With Inflammatory Bowel Disease: a Cross-sectional Study
Actual Study Start Date : July 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055130


Contacts
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Contact: Qingfan Yang, MD +860203866343 helengao818@163.com
Contact: Xiang Gao, PhD +860203866343 helengao818@163.com

Locations
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China, Guangdong
Department of Gastroenterology Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Qingfan Yang, MM    +8613450399302    yangchenyuyang@126.com   
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
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Study Director: Xiang Gao, PhD The sixth affiated hospital of Sun-Yat sen University
Additional Information:

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Responsible Party: Xiang Gao, Professor, Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03055130    
Other Study ID Numbers: HHBY-YJFA-20160813
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Papillomavirus Infections
Neoplasms
Uterine Cervical Neoplasms
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases