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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Crohns disease CD is a chronic inflammatory bowel disease that can severely impact patients quality of life by causing intestinal damage such as stenosis and fistulas, often leading to surgery. The goal of treatment has evolved from just clinical remission to achieving both clinical remission and healing of the intestinal lining, which reduces disease progression risks. The CALM strategy uses close monitoring of symptoms and biological markers like fecal calprotectin to guide treatment intensification and improve healing outcomes. Researchers are investigating whether adding MRI-based assessment of transmural healing to this approach can further reduce disease progression in patients receiving biotherapy. This randomized, open-label study compares two treatment strategies for adults with active Crohns disease starting biotherapy. One group follows the CALM strategy with regular clinical and biological monitoring, while the other group adds scheduled MRI evaluations to assess transmural healing. MRIs are performed at baseline, weeks 24, 52, 76, and 152 in the MRI group, with treatment intensification based on residual activity seen on imaging. Both groups receive biotherapy guided by French consensus guidelines, and patients are followed for approximately three years. Participants will be regularly monitored through clinical evaluations, fecal calprotectin tests, and MRIs as scheduled. They will keep a symptom diary recording abdominal pain and stool frequency monthly. Researchers will measure the proportion of time spent in clinical remission without corticosteroids between weeks 24 and 76 as the primary outcome. Safety and other secondary outcomes will be assessed centrally. The study will analyze data on an intention-to-treat basis and includes ongoing follow-up over nearly three years.
Actively Recruiting
Healthy Volunteer
Cancer treatment often involves surgery, chemotherapy, and radiotherapy, which can cause acute and chronic pain, including neuropathic pain that is hard to predict and treat. Many cancer patients experience chronic pain that significantly affects their quality of life. This research aims to validate a predictive tool to assess the risk of neuropathic pain and pain chronicity in cancer patients, considering factors like preoperative pain, opioid use, age, sleep, psychological state, and social vulnerability. The study involves 500 cancer patients with breast, gynecological, lung, or colorectal cancers, along with 125 healthy volunteers as controls. Participants will undergo assessments of cognitive, emotional, and pain-related factors through questionnaires. Data collection occurs at baseline, 6 months, and 12 months to evaluate pain intensity, neuropathic pain signs, cognitive function, emotional status, social vulnerability, quality of life, sleep quality, disease perception, and analgesic use. Participants will complete various validated questionnaires and scales at these time points to help researchers measure their pain trajectories and related factors. The primary outcome is the CANoPy score, assessed at baseline and during follow-up visits. The study tracks these measures over one year to understand pain development and its impact, aiming to improve predictive abilities for neuropathic pain in cancer management.