HPV-Related Cervical CarcinomaNCT03055130
HPV Infection and Cervical Neoplasm in Women With Inflammatory Bowel Disease: a Cross-sectional Study
An observational study of HPV-Related Cervical Carcinoma and Inflammatory Bowel Diseases, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV-Related Cervical Carcinoma, Inflammatory Bowel Diseases, Cervical Neoplasm
- What is being tested?
- Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologist
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Jul 2017
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- between 20-60 years old;
- Patients diagnosed as IBD according to previously established international criteria
Who cannot join
- 1. Patients refuse to participating
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology
Guangzhou, Guangdong, 510000
Qingfan Yang, MM, +8613450399302, yangchenyuyang@126.com
About this study
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.
- Being tested
- Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologist
- Medical subject headings
- Inflammatory Bowel Diseases, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologistOther
| Study group | Role | What they receive |
|---|---|---|
| Case group | Female IBD patients who had sexual life between 21-60 years-old were recruited. Receives: 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. Receives: Other: Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: July 2015 to July 2017
Secondary outcomes (1)
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.
Measured: July 2015 to July 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study startJul 2015
- Primary completionMay 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-Related Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Gao, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Xiang Gao, PhD, Study director, The sixth affiated hospital of Sun-Yat sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055130
- Sponsor's protocol ID
- HHBY-YJFA-20160813
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 16 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Infection and Cervical Neoplasm in Women With Inflammatory Bowel Disease: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03055130
- Acronym / sponsor ID
- HHBY-YJFA-20160813
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 16 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologistFemale IBD patients who had sexual life between 21-60 years-old were recruited. |
| control group | – | Other: Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologistFemale people who perform physical examination in our hospital between 21-60 years-old were recruited as control during the study period. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- between 20-60 years old;
- Patients diagnosed as IBD according to previously established international criteria
Key exclusion criteria (1 listed)
- 1. Patients refuse to participating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologist | Other | Case group, control group |
Primary outcome
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.
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.
1 secondary outcome
Find drugs relating to HPV infection of IBD patients
Time frame: July 2015 to July 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiang Gao, PhD study director
The sixth affiated hospital of Sun-Yat sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV-Related Cervical Carcinoma and Inflammatory Bowel Diseases, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingfan Yang, MD (+860203866343, helengao818@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.