Anal Squamous Intraepithelial Lesion (ASIL)ADIBDNCT01860963
Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls
A study testing Anal Pap smear and HPV DNA testing in people with Anal Squamous Intraepithelial Lesion (ASIL) and HPV DNA, run by Stanford University at 1 site in United States.
Trial summary
This study is designed to establish the prevalence of anal squamous intraepithelial lesion (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Anal Squamous Intraepithelial Lesion (ASIL), HPV DNA
- What is being tested?
- Anal Pap smear and HPV DNA testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2013
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All IBD patients followed in the IBD clinic and healthy controls who are greater than 18 years old
Who cannot join
- History of HPV vaccination
- Pregnancy
- Other immunosuppressed states (i.e. systemic lupus erythematosus, rheumatoid arthritis, cancer, Human Immunodeficiency Virus (HIV), transplant)
- IBD patients who don't meet immunosuppression/non-immunosuppression criteria
- Inability to obtain informed consent from patient
- Previous diagnosis of ASIL or anal/rectal cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Digestive Health Center
Stanford, California, 94305
About this study
Official title: Prevalence of Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls
This study is designed to establish the prevalence of anal squamous intraepithelial lesion (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.
Read the detailed description
IBD patients attending the Stanford Inflammatory Bowel Disease (IBD) clinic and age-matched healthy controls are screened for eligibility. Informed consent is obtained for eligible subjects. An anonymous self-administered questionnaire is administered to assess risk factors for HPV. For IBD patients, information regarding IBD diagnosis and treatment is obtained.
An anal pap smear is performed at the time of a clinic visit or at the time of an already scheduled colonoscopy. Samples are collected and processed at Stanford pathology where a blinded pathologist reads all specimens. Human Papillomavirus (HPV) DNA testing is performed on all specimens. All patients with anal squamous intraepithelial lesion (ASIL) are referred to a colorectal surgeon for further recommendations or treatment, which includes a high-resolution anoscopy.
- Being tested
- Anal Pap smear and HPV DNA testing
- Keywords
- ASIL, Anal dysplasia, IBD, HPV DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal Pap smear and HPV DNA testingProcedure or surgery
Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV.
| Study group | Role | What they receive |
|---|---|---|
| IBD patients on immunosuppression | Active comparator | Patients on azathioprine/6-mercaptopurine (6MP), prednisone, methotrexate, infliximab, adalimumab, certolizumab, natalizumab, and etanercept are included. Receives: Procedure: Anal Pap smear and HPV DNA testing |
| IBD patients off immunosuppressants | Active comparator | Patients off immunosuppressants, on 5-aminosalicylic acid (5-ASA) agents, antibiotics, or no treatment for IBD are included. Receives: Procedure: Anal Pap smear and HPV DNA testing |
| Healthy controls | Active comparator | Age-matched healthy controls enrolled from the hospital, outpatient clinics, and from the general public via flyers and online advertisements. Receives: Procedure: Anal Pap smear and HPV DNA testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of high risk HPV and/or abnormal cytology
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 posted23 May 2013 (estimated)
- Study startJan 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anal Squamous Intraepithelial Lesion (ASIL)Studies of the same condition, open and under way.
- More trials run by Stanford 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Welton, MD, Principal investigator, Stanford Hosptial and ClinicsShamita Shah, MD, Principal investigator, Stanford Hospital and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860963
- Sponsor's protocol ID
- MW-16467
- Acronym
- ADIBD
- Status last verified
- Sep 2013
- First submitted
- 21 May 2013
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shah SB, Pickham D, Araya H, Kamal A, Pineda CE, Ghole S, Shih L, Kong C, Pai R, Welton M. Prevalence of Anal Dysplasia in Patients With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1955-61.e1. doi: 10.1016/j.cgh.2015.05.031. Epub 2015 Jun 2.
PubMed 26044314
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls
- ClinicalTrials.gov ID
- NCT01860963
- Acronym / sponsor ID
- ADIBD / MW-16467
- Keywords
- ASIL, Anal dysplasia, IBD, HPV DNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 May 2013 (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.
This study is designed to establish the prevalence of anal squamous intraepithelial lesion (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.
Detailed description
IBD patients attending the Stanford Inflammatory Bowel Disease (IBD) clinic and age-matched healthy controls are screened for eligibility. Informed consent is obtained for eligible subjects. An anonymous self-administered questionnaire is administered to assess risk factors for HPV. For IBD patients, information regarding IBD diagnosis and treatment is obtained.
An anal pap smear is performed at the time of a clinic visit or at the time of an already scheduled colonoscopy. Samples are collected and processed at Stanford pathology where a blinded pathologist reads all specimens. Human Papillomavirus (HPV) DNA testing is performed on all specimens. All patients with anal squamous intraepithelial lesion (ASIL) are referred to a colorectal surgeon for further recommendations or treatment, which includes a high-resolution anoscopy.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBD patients on immunosuppression | Active comparator | Procedure: Anal Pap smear and HPV DNA testingPatients on azathioprine/6-mercaptopurine (6MP), prednisone, methotrexate, infliximab, adalimumab, certolizumab, natalizumab, and etanercept are included. |
| IBD patients off immunosuppressants | Active comparator | Procedure: Anal Pap smear and HPV DNA testingPatients off immunosuppressants, on 5-aminosalicylic acid (5-ASA) agents, antibiotics, or no treatment for IBD are included. |
| Healthy controls | Active comparator | Procedure: Anal Pap smear and HPV DNA testingAge-matched healthy controls enrolled from the hospital, outpatient clinics, and from the general public via flyers and online advertisements. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All IBD patients followed in the IBD clinic and healthy controls who are greater than 18 years old
Key exclusion criteria (6 listed)
- History of HPV vaccination
- Pregnancy
- Other immunosuppressed states (i.e. systemic lupus erythematosus, rheumatoid arthritis, cancer, Human Immunodeficiency Virus (HIV), transplant)
- IBD patients who don't meet immunosuppression/non-immunosuppression criteria
- Inability to obtain informed consent from patient
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 and HPV DNA testingAnal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV. | Procedure or surgery | Healthy controls, IBD patients off immunosuppressants, IBD patients on immunosuppression |
Primary outcome
Presence of high risk HPV and/or abnormal cytology
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 1 Oct 2013.
- Derived from this study: PubMed 26044314Shah SB, Pickham D, Araya H, Kamal A, Pineda CE, Ghole S, Shih L, Kong C, Pai R, Welton M. Prevalence of Anal Dysplasia in Patients With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1955-61.e1. doi: 10.1016/j.cgh.2015.05.031. Epub 2015 Jun 2.
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.
Mark Welton, MD principal investigator
Stanford Hosptial and Clinics
Shamita Shah, MD principal investigator
Stanford Hospital and Clinics
1 site 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 and HPV DNA testing in people with Anal Squamous Intraepithelial Lesion (ASIL) and HPV DNA, run by Stanford University at 1 site 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 1 inclusion and 6 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 1 Oct 2013. 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 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?
Presence of high risk HPV and/or abnormal cytology (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01860963, which also lists 1 linked publication.
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 1 Oct 2013.