Actively Recruiting
Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease
Led by Connecticut Children's Medical Center · Updated on 2025-09-23
900
Participants Needed
26
Research Sites
316 weeks
Total Duration
On this page
Sponsors
C
Connecticut Children's Medical Center
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Crohn's disease (CD) is a condition that causes inflammation (swelling, redness) of the lining and wall of the small intestine, large intestine, or both. CD may be associated with abdominal cramps/pain, diarrhea, blood in the stool, weight loss, or delayed growth in children. While the exact cause of CD is not certain it is thought that the immune system located in the intestine reacts abnormally to the large number of bacteria contained there. The investigators think that diet, exposure to antibiotics early in life, and having a family history of CD puts people at increased risk for developing CD. In order to decrease the inflammation doctors use what is called biologic therapy with anti-TNF molecules that can be given through an intravenous or shots. TNF is a chemical made by white blood cells that is involved in inflammation. When this type of treatment is given early after diagnosis it is more effective than when it is given later. The investigators have learned that it is important to give the optimum (ideal) amount of this medicine guided by certain blood tests. The investigators also know that not everyone responds to this therapy but do not understand the reasons for this variability between people. The CAMEO study has been started to help understand what factors are important in determining whether a child with CD completely heals the inflammation after anti-TNF therapy. The investigators will do that by measuring certain markers of inflammation in the blood and stool and by looking at a person's genes (DNA) and how inflammation is controlled in the intestine. These inflammation tests will be done before, during, and after one year of anti-TNF therapy. The investigators will determine how much healing has taken place by comparing the results of the colonoscopy and a special type of MRI that are both done before anti-TNF and then again one year later. The goal in treating CD is to heal both the lining and the wall of the intestine. Children ages 6-17 years who are thought to have CD and are about to undergo their diagnostic colonoscopy are eligible to be enrolled. If they are found to indeed have CD and start an anti-TNF medicine within 6 months they can continue in the study. There are no increased risks of participating in this study beyond those normally associated with having CD and its treatment. By better understanding why the bowel does or does not heal, doctors will be better able to provide personalized care.
CONDITIONS
Official Title
Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 years or older and younger than 18 years at enrollment
- Suspected diagnosis of Crohn's disease
- Negative stool culture for routine pathogens and Clostridium difficile toxin if diarrhea is present
- Parent or guardian consent and patient assent
- Ability to remain in follow-up for at least 6 months initial observation plus 52 weeks after starting anti-TNF therapy
- Diagnosed with macroscopic Crohn's disease involving the terminal ileum and/or colon by endoscopic evaluation and/or MRI enterography
- MRI enterography performed within 6 weeks of ileocolonoscopy and no more than 4 weeks after starting initial therapy
- Received initial therapy including corticosteroids, immunomodulators, aminosalicylic acids, defined nutritional therapy, or anti-TNF (adalimumab or infliximab)
- Commenced anti-TNF therapy guided by ROADMAB CDST as first therapy or within 180 days of diagnosis
- Ileal and rectal biopsies obtained or documented inflammation preventing ileal biopsies
- Ability to remain in follow-up for at least 52 weeks after starting anti-TNF therapy
You will not qualify if you...
- Diagnosis of Crohn's disease following abdominal surgery or appendectomy at initial presentation
- High likelihood (>50%) of needing bowel resection within 3 months of diagnosis
- Use of oral corticosteroids for non-gastrointestinal reasons within 4 weeks prior to assessment
- Use of investigational drugs within 4 weeks prior to assessment
- Pregnancy
- Poorly controlled medical conditions such as diabetes or congestive heart failure
- Previous treatment with immunomodulators within 1 year or anti-TNF therapy within 2 years for other conditions
- Previous treatment with non-anti-TNF biologics or small molecules for non-IBD indications in past 6 months except dupilumab
- Inability to undergo MRI enterography due to claustrophobia or other reasons
- Diagnosis of Crohn's disease by video capsule endoscopy only with normal ileocolonoscopy and MRI
- Orofacial Crohn's disease only
- Esophageal, gastric, duodenal, or jejunal Crohn's disease only
- Severe complex fistulizing perianal disease requiring or likely to require surgical intervention
- Perianal Crohn's disease only with no luminal disease
- Internal fistulizing disease at diagnosis
- Initial treatment with non-anti-TNF biologic or small molecule therapy
- Received any anti-TNF agent other than adalimumab or infliximab
- Unlikely to return for follow-up visits
- Video of baseline endoscopy not available for central reading unless approved
- Underwent bowel resection within 3 months of diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Cedars-Sinai
Los Angeles, California, United States, 90048
Actively Recruiting
3
Rady Children's Hospital - San Diego and University of California, San Diego
San Diego, California, United States, 92123
Actively Recruiting
4
UCSF Benioff Children's Hospitals
San Francisco, California, United States, 94158
Actively Recruiting
5
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
6
Emory University
Atlanta, Georgia, United States, 30328
Actively Recruiting
7
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
The Johns Hopkins Children's Medical Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
9
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
10
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
Goryeb Children's Hospital/Morristown Medical Center/Atlantic Children's Health
Morristown, New Jersey, United States, 07960
Actively Recruiting
12
Cohen Children's Medical Center of NY
Lake Success, New York, United States, 11042
Actively Recruiting
13
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
14
Levine Children's
Charlotte, North Carolina, United States, 28203
Actively Recruiting
15
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
16
UH/Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
17
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
18
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19146
Actively Recruiting
19
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
20
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
21
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
22
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
23
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 1C9
Actively Recruiting
24
Children's Hospital Western Ontario
London, Ontario, Canada, N6A 5W9
Actively Recruiting
25
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Actively Recruiting
26
Toronto SickKids Hospital
Toronto, Ontario, Canada, M5G1X8
Actively Recruiting
Research Team
D
Dena E Hopkins, MPH, CCRP
CONTACT
J
Jeffrey S Hyams, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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