An Observational Study: 5-year Long-Term Study of Patients Undergoing Therapy for Inflammatory Bowel Disease

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"Researchers are collecting information on patients with inflammatory bowel disease (IBD). Help us learn how to better treat and manage it!"
Age: 2 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Inflammatory Bowel Disease, IBD, Crohn’s disease, CD, ulcerative colitis, UC, Indeterminate Colitis, IBDU, gastrointestinal, GI
Type: Observational Study
Target:
100 Participants
Investigator:
Description
You are being asked to be in this research study because you have inflammatory bowel disease (IBD). This includes Crohn’s disease (CD), ulcerative colitis (UC), and Indeterminate Colitis (IBDU). These are chronic inflammatory disorders of the gastrointestinal (GI) tract.

The goals of this study are to collect information on patients with IBD. We hope to determine the natural course of the disease and to determine how procedures or treatments may affect IBD and general health. This research study intends to observe any treatment for IBD in a “real life” setting. Researchers will observe how these treatments, lifestyle changes, and counseling work for patients.

We will collect information about which treatments are being used and your response to these treatments. We hope this will help researchers better understand how to manage IBD.

By doing this study, researchers hope to:
• Find out more about patients who have IBD including their age, race/ethnicity, and other medical conditions they may have
• Learn more about how often patients with IBD need to go to the hospital or have surgery
• Learn about different medications, supplements and other treatments that are being used to manage IBD and how they may affect certain types of patients
• Understand the effects of different durations, timing, sequences and medicines for IBD therapy in different groups of patients
• Learn more about the different side effects of IBD treatment in the ‘real world’. For example, researchers hope to learn about the number of side effects, how side effects are treated, and the number or type of side effects that may cause patients to stop IBD treatment
• Understand the different interactions between therapies used for IBD and other medicines patients may be taking
• Better understand how different treatments affect what patients are able to do and how they feel
• Learn about the long-term effects of IBD treatment on patients’ health
• Create a “Biorepository Specimen Bank” with blood samples
This study requires

If you agree to take part in this study and qualify to enroll in the study, there will be a Screening/Enrollment Visit and a Follow-Up Period.

Screening/Enrollment Visit (Visit 1) You will enrolld at a regularly-scheduled clinic visit. The following will occur at the visit:

  • Consent to main observational study

  • Review study criteria to determine if you are eligible for the study

  • Complete demographic data form including: o Year of birth o Gender o Race o Ethnicity (Hispanic or non-Hispanic) o Weight o Height o Smoking status o Insurance type

Following the Screening/Enrollment visit, up to three years of your historical medical records may be collected, redacted, and sent to the study sponsor, TARGET PharmaSolutions, Inc.

You may also choose to take part in optional sub-studies beyond the main observational study:

  • Optional Sub-Study #1: Blood sample collection

  • Optional Sub-Study #2: Questionnaires

  • Optional Sub-Study #3: Link of your health information to an external healthcare database

If you consent to Sub-Study #1, a blood sample (approximately 1 tablespoon) will be collected from you. When possible, this sample will be collected during regular clinical bloodwork. If it is not possible to do so, blood will be collected by a separate needlestick.

If you consent to Sub-Study #2, you will complete patient reported outcome (PRO) questionnaires at your initial visit and at up to 3-month intervals on paper.

If you consent to Sub-Study #3, your health information will be linked to an external healthcare database. The details of the optional sub-studies and their respective consent forms are further outlined at the end of this document.

Follow-Up Period (Months 6-60) The Follow-Up period will start at Month 6 (6 months following your initial visit) and will continue for up to 5 years (Month 60). Your medical records will be collected throughout this follow up period, redacted, and sent to the study sponsor. If you consented to the optional patient questionnaires, you will be asked to complete these assessments at up to 3-month intervals. If you consented to the optional blood sample, you will be asked to provide an annual blood sample (approximately 1⁄2 tablespoon). No other study procedures are required during this time. At Month 60, your participation in the study will be complete and no additional medical records will be collected.

Who can participate

Inclusion criteria:

  1. Adults and children (age 2 or older) with a diagnosis of Crohn's disease (CD), Ulcerative colitis (UC), or Indeterminate colitis (IBDU) having been prescribed any IBD treatment (initial or subsequent) outside of a clinical trial.
  2. Have plans for future visits at the site for continued management of IBD.

Exclusion criteria:

  1. Inability to provide written informed consent/assent.
  2. Being enrolled in any interventional study or trial for IBD treatment. Note: Patient may be enrolled in other registries or studies where IBD treatment outcomes are observed and/or reported (such as center-based registries).
  3. Prior total abdominal colectomy for UC or IBDU.
Benefits and risks of participating
BENEFITS:

Since this study is observational, it will not add any benefits beyond those of your normal care for IBD. We hope future patients will receive better treatment and experience fewer complications related to their disease.

RISKS:

The main risk of participation in this study is loss of confidentiality. This will be safeguarded with appropriate precautions, such as redacting your medical records. We will store the codes linking your identity to your Study ID in a secure, password-protected database. Only the research team can access this database.

If you agree to take part in the optional study involving additional blood draws, there may be blood draw risks. These risks include bruising, bleeding from the puncture site, discomfort where the blood was taken, infection, formation of a blood clot or swelling of the vein and surrounding tissue, and fainting.
Compensation
You will not be compensated for taking part in this study.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 5 years.
Recruitment period
From Nov. 14, 2017
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Sophia Zaragoza
Research Topic
Conditions:
  • Inflammatory Bowel Diseases
  • Crohn's Disease
  • Ulcerative Colitis
  • Indeterminate Colitis