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Actively Recruiting

Crohn's disease is a chronic inflammatory bowel condition that can severely impact patients' quality of life and often leads to intestinal damage requiring surgery. This trial investigates whether combining a standard close monitoring strategy using clinical symptoms and fecal calprotectin with additional MRI scans to assess transmural healing improves long-term remission in patients treated with biotherapy. The study explores if this combined "CALM + MRI" approach is better than the traditional "CALM" strategy alone for maintaining symptom-free periods without corticosteroids. Participants are randomly assigned to one of two groups: the reference group follows the CALM strategy with regular visits and treatment adjustments based on clinical symptoms and fecal calprotectin levels at multiple time points up to week 152 (about 3 years). The investigational group receives the same follow-up plus extra MRI scans at weeks 24 and 52, with treatment intensifications if MRI indicates ongoing disease activity. All participants undergo MRI at the beginning, week 76, and week 152. Treatment changes follow established French guidelines. Monthly symptom diaries track abdominal pain and stool frequency. Throughout the 152-week study, patients have evaluations including clinical assessments, fecal calprotectin tests, and MRIs to monitor disease activity and healing. The main outcome measured is the proportion of months patients spend in clinical remission between weeks 24 and 76. Secondary outcomes include response rates and imaging-based healing measures reviewed centrally to minimize bias. Missing data are handled by considering those months as non-remission periods. This comprehensive follow-up aims to determine if adding MRI to close clinical and biological monitoring provides better disease control.

Age: 18Years +All GendersPhase Not Applicable
17 locations
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Actively Recruiting

Healthy Volunteer

Neuropathic pain related to cancer and its treatments such as surgery, chemotherapy, and radiotherapy can cause acute and chronic pain that affects quality of life. Around 58% of cancer patients experience chronic neuropathic pain, which is often hard to treat and can persist after cancer remission. Many factors like preoperative pain intensity, opioid use, age, sleep problems, and psychological vulnerability influence chronic pain development, but there is currently no simple tool to predict individual risk before treatment begins. This research collects cognitive-emotional and pain-related data through questionnaires to validate a predictive tool that helps estimate the risk of neuropathic pain in cancer patients. The focus is on patients with breast, gynecological, colorectal, or lung cancer who are about to undergo anticancer therapies such as chemotherapy, surgery, hormonal therapy, radiotherapy, or targeted therapy. The study aims to optimize treatment by identifying patients more vulnerable to developing chronic neuropathic pain. Participants provide data through assessments of cognitive-emotional states and pain parameters. The main outcomes measured are CANoPy scores at baseline, 6 months, and 12 months to track pain progression. Patients must understand and cooperate with study requirements and give oral consent. The study also includes healthy volunteers for comparison. Participants are monitored throughout the study to evaluate the predictive tool's ability to identify those at risk of chronic neuropathic pain.

Age: 18Years +All GendersPhase Not Applicable
19 locations
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