Who Can Participate in CAMEO?
Children between the ages of 6 and 17 years can be considered for enrollment. There are two phases of CAMEO.
Phase 1 starts when there is a consideration for Crohn’s disease as a cause of symptoms and a colonoscopy is scheduled. Before the colonoscopy is performed, and after written informed consent, your doctor will ask for a special stool sample to examine for the large array of microbes (germs) present in the stool.
At the time of diagnostic colonoscopy, we will record a video of the procedure and take several small biopsies (pieces of tissue) to look for inflammation. These biopsies are routinely taken during colonoscopies to look for inflammation. Participants will also have a special type of MRI of the bowel called MRE (magnetic resonance enterography) that looks for inflammation in the small bowel. The MRE is considered standard-of-care in evaluating children for possible Crohn’s disease. Both the colonoscopy and MRE will be reviewed by experts in Crohn’s disease who will not be aware of your identity or symptoms. This gives us a completely impartial assessment of inflammation.
If a diagnosis of Crohn’s disease is made, you can continue in the study.
If you and your doctor decide to use anti-TNF biologics to treat your Crohn’s disease within 6 months of diagnosis, then you can continue in the study for Phase 2 following a second written consent. During Phase 2, a specialized computer program will help guide optimal anti-TNF therapy dosing, and blood and stool samples will be tested periodically for inflammation. We will try to take the study blood samples when other blood tests are already being done for routine care to avoid an additional stick.
If you do well on anti-TNF therapy, then one year later the colonoscopy and MRE will be repeated to see if the intestine has healed. These follow up tests are now routinely used in general clinical practice when caring for children with Crohn’s disease to assess the success of therapy.
How Will I Benefit From Being in CAMEO?
For patients receiving anti-TNF therapy, the study will provide free monitoring of drug levels. This is a blood test that shows how much of the anti-TNF is in your body. Normally this would be partly paid for by insurance and/or out-of-pocket by you. The MRE will be paid for by the study at one year if your doctor was not going to order it at that time for routine care. It is our hope that the results of this study will help determine response and remission rates, as well as likelihood of bowel healing, to the best current treatment approaches, and help us further develop even better ways to take care of children with Crohn’s disease.
Is There Any Risk to Enrolling in CAMEO?
CAMEO is designed to closely follow what we call “standard of care.” That means that all the study activities are generally ones that your doctor would be doing anyway. What is different is the collection of blood samples, stool, and biopsy specimens for research purposes. The collection of these specimens does not add any specific risk beyond that normally found in clinical practice. It may be inconvenient to collect extra stool specimens for research purposes. There is a remote possibility that patient confidentiality might be lost in data collection, but every effort is made to minimize this possibility. Each patient will be given a unique study number and only their center/hospital will know their name.
Why Are We Doing This Study?
While therapies for Crohn’s disease have dramatically improved over the past 25 years, there are still children who continue to have symptoms and may have progression of disease leading to surgery. It is the goal of the hundreds of people involved in this study to help us better understand why there is inflammation in the bowel in Crohn’s disease and how best to treat it. While CAMEO focuses on the response to anti-TNF medications, we also believe that the information we gain from this study may help us in developing future and even better approaches.