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Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed With Crohn's Disease

Study acronym: CAMEO
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Site details revised at 4 of 26 sitesv27
  2. Minor Site contacts updated at 5 of 26 sitesv26
  3. Minor Site contacts updated at 3 of 26 sitesv25
  4. Minor Eligibility criteria expanded, about 38 words
    • Site contacts updated at 1 of 26 sites
    v24
  5. Minor Site contacts updated at 2 of 26 sitesv23
Show 21 earlier versionsHide 21 earlier versions
  1. Minor Study Status, Referencesv22
  2. Minor Site details revised at 1 of 26 sitesv21
  3. Minor Site details revised at 2 of 26 sitesv20
  4. Minor Eligibility criteria expanded, about 55 words
    • Site details revised at 1 of 26 sites
    v19
  5. Notable Phase: Not specified to Phase 4
    • Interventions: infliximab, adalimumab (Biological) to Anti-TNF therapy (Drug)
    v18
  6. Minor Eligibility criteria expanded, about 24 wordsv17
  7. Minor Site details revised at 1 of 26 sitesv16
  8. Minor Site details revised at 9 of 26 sitesv15
  9. Minor Site details revised at 1 of 26 sitesv14
  10. Minor Site details revised at 2 of 26 sitesv13
  11. Minor Site details revised at 2 of 26 sitesv12
  12. Minor Site details revised at 1 of 26 sitesv11
  13. Minor Site details revised at 2 of 26 sitesv10
  14. Minor Site details revised at 2 of 26 sitesv9
  15. Minor Site details revised at 1 of 26 sitesv8
  16. Minor Site details revised at 1 of 26 sitesv7
  17. Minor Site details revised at 2 of 26 sitesv6
  18. Minor Site details revised at 2 of 26 sitesv5
  19. Minor Site details revised at 2 of 26 sitesv4
  20. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 27 to 26
    • Start date changed from estimate of Jul 1, 2023 to Jun 10, 2023
    v3
  21. Notable Start date: Apr 1, 2023 to Jul 1, 2023
    • Primary completion date: Apr 1, 2028 to Jul 1, 2028
    • Study completion date: Apr 1, 2029 to Jul 1, 2029
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05781152
Lead Sponsor Connecticut Children's Medical Center
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Emory University, Children's Hospital Medical Center, Cincinnati, University of North Carolina, Chapel Hill
Conditions
(from sponsor)
Crohn Disease
Related terms Crohn Disease, Inflammatory Bowel Diseases
Enrollment 900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov