Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of Pittsburgh
With
Treatment of IBD relies on disease modification by induction of relative immunosuppression with corticosteroids and latterly and increasingly, by the use of immunomodulators (azathioprine, mercaptopurine, methotrexate), biological agents such as anti tumor necrosis factor monoclonal antibodies (infliximab, adalimumab, certolizumab) or with a circulating receptor fusion protein (etanercept). These agents impair cell mediated immunity (CMI) and have been associated with increased rates of both tuberculosis and fungal infections in treated populations beyond that seen with corticosteroids alone. Following initial infection, HPV is controlled by CMI and manifestations of infection become increasingly clinically apparent when CMI is impaired due to for example HIV co-infection or systemic immunosuppression. There is appropriate concern in the IBD treatment community that the use of immunosuppression to modify disease course may lead to increased rates of HPV associated disease including warts, dysplasia and ultimately anogenital cancer above and beyond the established increased risk associated with IBD. In this context it is important to establish the prevalence of both HPV infection and anal dysplasia in patients with IBD before and after treatment with a non-steroid immunosuppressive agent. These data will help determine the need for HPV vaccination and/or anal dysplasia screening in patients with IBD. VISIT 1 (Screening/Enrollment Visit): This visit will include: * Medical/medication history. * Physical exam as per standard of care * Females of reproductive potential will give a urine sample for a pregnancy test. This test must be negative. * An anal Pap test for abnormal cells. The researcher will insert a swab (similar to a Q-tip) into the anus. The end of the swab will be rubbed against the skin inside the anus. * An anal swab to test for HPV (using the same method as the anal Pap) * Female participants will also have a vaginal swab for HPV. This may be self taken, or taken by a clinician. * An exam of the anus and genital area for any lesions or masses. * A rectal exam with a finger to feel for any abnormalities. * An anal exam called high resolution anoscopy (HRA) that uses a special microscope and dyes to examine the anus for abnormal areas. A lubricated plastic speculum will be inserted into the anus. Then, a swab moistened with acetic acid is placed in the anus so that abnormal areas will be visible. A colposcope will be used to view the skin inside the anus. A biopsy, with or without iodine for visualization of the abnormal areas, may be taken if any lesions have the appearance of high-grade anal dysplasia or other abnormal findings. Within 1 day after this visit, study staff will telephone the participant to ask about any side effects or health problems from the study procedures. If necessary, the participant may be asked to come to the clinic for a visit. VISIT 2 (Final Visit): This visit will occur 6 to 12 months after the first visit. Prior to this visit, participant will be instructed to not have anal sex or insert anything into the anus, including enemas, for 24 hours before each study visit. This visit will include: * Medical/medication history * Physical exam as per standard of care * Females of reproductive potential will give a urine or 5ml blood sample\] for a pregnancy test. This test must be negative. * Anal Pap test for abnormal cells * Anal swab for HPV * Females participants will also have a vaginal swab for HPV * An exam of the anus and genital area for any lesions, tenderness or masses * A rectal exam to feel for any abnormalities * High-resolution anoscopy (HRA). A biopsy, with or without iodine for visualization of the abnormal areas, may be taken if any lesions have the appearance of high-grade anal dysplasia or other abnormal findings. Within 1 day after this visit, study staff will telephone the participant to ask about any side effects or health problems from the study procedures. If necessary, the participant may be asked to come to the clinic for a visit.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
