IBDHPVIBDNCT01653054
Anal Dysplasia in Patients With Inflammatory Bowel Disease
A study testing Anal Pap Smear, HPV DNA Testing in people with IBD, run by Montefiore Medical Center at 2 sites in United States.
Trial summary
The rationale for this study is that the risk of anal dysplasia in patients with inflammatory bowel disease (IBD) as compared to the general population has yet to be investigated prospectively. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IBD
- What is being tested?
- Anal Pap Smear, HPV DNA Testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2011to 29 Sep 2015
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- i. Women and men between the ages of 18-65 with a history of inflammatory bowel disease confirmed histologically and on immunosuppression defined as at least three months of azathioprine/6MP, eight consecutive weeks of prednisone greater than 15mg per day, a cumulative dose of greater than 100mg of methotrexate, or at least one infusion of infliximab within 8 weeks of the date of the anal Pap smear.
- Women and men between the ages of 18-65 with a history of inflammatory bowel disease confirmed histologically and not on immunosuppression (defined as above)
Who cannot join
- i. Patients with HIV, transplant recipients, men who have sex with men as they already represent high risk groups ii. Women with a history of an abnormal cervical Pap test within the past 2 years.
- Patients with active proctitis as defined by an abnormal sigmoidoscopy or colonoscopy, rectal bleeding or tenesmus.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stony Brook University Hospital
Stony Brook, New York, 11794
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: The Incidence of Abnormal Anal Pap Smears in Patients With Inflammatory Bowel Disease
The rationale for this study is that the risk of anal dysplasia in patients with inflammatory bowel disease (IBD) as compared to the general population has yet to be investigated prospectively. There have only been a few articles examining this relationship - preliminary results have suggested that patients with IBD are at increased risk for abnormal anal pap smears. As high grade anal dysplasia is strongly associated with an increased risk of anal carcinoma, it is important to identify all high risk groups that might benefit from routine screening. This pilot study aims to determine whether patients with IBD in our Bronx population have an increased risk of abnormal anal Pap smears. We hypothesize that there will be an increased incidence of abnormal anal pap smears in patients with IBD who have been treated with immunosuppressants, given that chronic immunosuppression is related to increased HPV infection.
Read the detailed description
IBD patients on and off immunosuppression will be identified from gastroenterology fellow clinics. After patients express interest in the study, a study coordinator will provide an overview of the study and obtain consent prior to initiating any research related procedures. Anal Pap smears and Digene Hybrid Capture 2 High-Risk HPV DNA Tests will be performed on each study patient.
Medications will be documented for all IBD subjects and controls. Patient characteristics that will be documented will include IBD diagnosis, area of involvement (small bowel vs. large bowel, rectal involvement), type and duration of immunosuppressant use, smoking status, family history of any dysplasia (including anus), and reproductive risk factors. Data will be reported by subjects in subject interviews and through questionnaires.
For the purposes of analysis, subjects will be divided into two groups: IBD patients on immunosuppression and IBD patients not on immunosuppression. Results will be recorded in relation to exposure to immunosuppressive agents including prednisone, purine analogs (azathioprine/6MP), methotrexate, and infliximab. Immunosuppression will be defined as a history of at least three months of azathioprine/6MP, eight consecutive weeks of prednisone greater than 15mg per day, a cumulative dose of greater than 100mg of methotrexate, or at least one infusion of infliximab within 8 weeks of the date of the anal Pap smear. Since this is a pilot project, we will recruit a minimum of 20 subjects to each group.
Abnormalities will be classified in standard Bethesda classifications as atypical squamous cells of undetermined significance (ASCUS), low grade squamous intraepithelial lesion (LSIL), high grade squamous intraepithelial lesion (HSIL) or carcinoma. The pathologist reading the Pap smears will be blinded to the patient status (IBD versus control) and immunomodulator history.
- Conditions
- IBD
- Being tested
- Anal Pap Smear, HPV DNA Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal Pap Smear, HPV DNA TestingProcedure or surgery
Anal Pap Smears and HPV DNA testing will be performed on all subjects.
| Study group | Role | What they receive |
|---|---|---|
| IBD patients ON Immunosuppression | Experimental | Not described Receives: Procedure: Anal Pap Smear, HPV DNA Testing |
| IBD Patients OFF Immunosuppression | Experimental | Not described Receives: Procedure: Anal Pap Smear, HPV DNA Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abnormal anal cytology and presence of high risk HPV DNA
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startOct 2011
- Primary completion29 Sep 2015
- Study completion29 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence Brandt, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653054
- Sponsor's protocol ID
- 11-01-050E
- Acronym
- HPVIBD
- Status last verified
- Apr 2018
- First submitted
- 26 Jul 2012
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Abnormal Anal Pap Smears in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT01653054
- Acronym / sponsor ID
- HPVIBD / 11-01-050E
- Conditions
- IBD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- 29 Sep 2015 (actual)
- Study completion
- 29 Sep 2015 (actual)
- First posted
- 30 Jul 2012 (estimated)
- 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 rationale for this study is that the risk of anal dysplasia in patients with inflammatory bowel disease (IBD) as compared to the general population has yet to be investigated prospectively. There have only been a few articles examining this relationship - preliminary results have suggested that patients with IBD are at increased risk for abnormal anal pap smears. As high grade anal dysplasia is strongly associated with an increased risk of anal carcinoma, it is important to identify all high risk groups that might benefit from routine screening. This pilot study aims to determine whether patients with IBD in our Bronx population have an increased risk of abnormal anal Pap smears. We hypothesize that there will be an increased incidence of abnormal anal pap smears in patients with IBD who have been treated with immunosuppressants, given that chronic immunosuppression is related to increased HPV infection.
Detailed description
IBD patients on and off immunosuppression will be identified from gastroenterology fellow clinics. After patients express interest in the study, a study coordinator will provide an overview of the study and obtain consent prior to initiating any research related procedures. Anal Pap smears and Digene Hybrid Capture 2 High-Risk HPV DNA Tests will be performed on each study patient.
Medications will be documented for all IBD subjects and controls. Patient characteristics that will be documented will include IBD diagnosis, area of involvement (small bowel vs. large bowel, rectal involvement), type and duration of immunosuppressant use, smoking status, family history of any dysplasia (including anus), and reproductive risk factors. Data will be reported by subjects in subject interviews and through questionnaires.
For the purposes of analysis, subjects will be divided into two groups: IBD patients on immunosuppression and IBD patients not on immunosuppression. Results will be recorded in relation to exposure to immunosuppressive agents including prednisone, purine analogs (azathioprine/6MP), methotrexate, and infliximab. Immunosuppression will be defined as a history of at least three months of azathioprine/6MP, eight consecutive weeks of prednisone greater than 15mg per day, a cumulative dose of greater than 100mg of methotrexate, or at least one infusion of infliximab within 8 weeks of the date of the anal Pap smear. Since this is a pilot project, we will recruit a minimum of 20 subjects to each group.
Abnormalities will be classified in standard Bethesda classifications as atypical squamous cells of undetermined significance (ASCUS), low grade squamous intraepithelial lesion (LSIL), high grade squamous intraepithelial lesion (HSIL) or carcinoma. The pathologist reading the Pap smears will be blinded to the patient status (IBD versus control) and immunomodulator history.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD patients ON Immunosuppression | Experimental | Procedure: Anal Pap Smear, HPV DNA Testing |
| IBD Patients OFF Immunosuppression | Experimental | Procedure: Anal Pap Smear, HPV DNA Testing |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- i. Women and men between the ages of 18-65 with a history of inflammatory bowel disease confirmed histologically and on immunosuppression defined as at least three months of azathioprine/6MP, eight consecutive weeks of prednisone greater than 15mg per day, a cumulative dose of greater than 100mg of methotrexate, or at least one infusion of infliximab within 8 weeks of the date of the anal Pap smear.
- Women and men between the ages of 18-65 with a history of inflammatory bowel disease confirmed histologically and not on immunosuppression (defined as above)
Key exclusion criteria (2 listed)
- i. Patients with HIV, transplant recipients, men who have sex with men as they already represent high risk groups ii. Women with a history of an abnormal cervical Pap test within the past 2 years.
- Patients with active proctitis as defined by an abnormal sigmoidoscopy or colonoscopy, rectal bleeding or tenesmus.
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 |
|---|---|---|
| Anal Pap Smear, HPV DNA TestingAnal Pap Smears and HPV DNA testing will be performed on all subjects. | Procedure or surgery | IBD Patients OFF Immunosuppression, IBD patients ON Immunosuppression |
Primary outcome
Abnormal anal cytology and presence of high risk HPV DNA
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
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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.
Lawrence Brandt, MD principal investigator
Montefiore Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anal Pap Smear, HPV DNA Testing in people with IBD, run by Montefiore Medical Center at 2 sites in United States.
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 2 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: finished, as of the sponsor's last update on 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abnormal anal cytology and presence of high risk HPV DNA (time frame: 1 day). 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 25 Apr 2018.