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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

Head and Neck squamous cell carcinoma HNSCC has a 5-year survival rate of about 50 across all stages, with early stage I and II patients having better outcomes. This research focuses on improving early diagnosis of HNSCC by using a novel ultra-sensitive next generation sequencing NGS assay to detect circulating tumor DNA ctDNA in the blood, which is shed by cancer cells. The study aims to assess the sensitivity and specificity of this blood test in identifying early-stage HNSCC, potentially speeding up diagnosis and treatment pathways. This observational study uses a simple blood test liquid biopsy to detect ctDNA, including HPV DNA and genetic alterations associated with head and neck cancer. The assay offers a rapid turnaround time of 1 to 2 weeks, which may help reduce delays in the cancer referral and treatment process, especially in secondary care hospitals. The test is being evaluated in patients referred for ultrasound-guided fine needle aspiration in neck lump clinics, with no experimental drug or device intervention involved. Participants will provide blood samples during their clinic visits to allow researchers to measure the assays accuracy in detecting ctDNA. The main outcome is the tests sensitivity for early HNSCC detection within one year, alongside its specificity at baseline. The study involves routine clinical assessments and sample collection, with no additional treatment given. The total participation time varies, focusing on sample analysis and follow-up to understand the assays potential in earlier cancer diagnosis and improved patient outcomes.

Age: 18Years +All Genders
2 locations
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Actively Recruiting

This research aims to improve the accuracy of MRI scans in detecting early-stage rectal cancer and significant rectal polyps. Many patients with early rectal cancer currently undergo major surgery or unnecessary treatments due to inaccurate staging. The study evaluates a new MRI reading method called PRESERVE, which has been shown to identify early rectal cancers more accurately and may allow more patients to have less invasive local excision surgery that preserves the rectum and quality of life. The study compares two phases a control phase where patients receive standard care, and an intervention phase following training of radiologists in the PRESERVE MRI staging method. During the intervention phase, MRI scans are recommended for rectal polyps 20mm or larger or with suspicious features before removal, alongside radiologist training. Each hospital transitions from control to intervention at a randomized time, with no crossover of patients between phases. Participants will be monitored through clinical investigations before, during, and after treatment as per standard care. Researchers will assess the accuracy of tumor staging on MRI, the number of patients identified for rectal preservation surgery, and quality of life outcomes over up to 5 years. Additional measures include scan quality, tumor characteristics, treatment costs, and histopathological biomarkers. The primary outcome is the impact of radiologist training on staging accuracy measured after one year.

Age: 16Years - 100YearsAll GendersPhase Not Applicable
23 locations
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Actively Recruiting

Researchers are evaluating the real-world use of nemolizumab for treating moderate-to-severe atopic dermatitis AD in adolescents and adults. This observational study aims to assess the treatments effectiveness through physician evaluations and patient-reported outcomes over six months, providing insight into how the medication performs in everyday clinical practice. Participants receiving nemolizumab as part of their routine care will be observed for about 12 months. Treatment decisions are made by the participants physician before joining the study, with no extra visits or tests beyond usual medical care. A sub-study in Germany and the UK involves daily remote reporting of symptoms such as peak and average itch, sleep disturbance, and pain for the first two weeks. During the study, participants will have regular medical visits as determined by their doctors, with data collected from routine assessments and patient questionnaires. Researchers will measure outcomes like the Investigator Global Assessment and Peak Pruritus Numerical Rating Scale at six months, along with other severity and symptom scores up to 12 months. No additional procedures outside standard care are required, allowing for natural monitoring of treatment effects and safety.

Age: 12Years +All Genders
108 locations
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Actively Recruiting

Researchers are studying patients with newly diagnosed stage I, II, and III colorectal cancer CRC to understand how circulating tumor DNA ctDNA in the blood can predict disease relapse. The study evaluates whether using ctDNA to guide adjuvant chemotherapy decisions after surgery is as effective as standard chemotherapy, aiming to reduce unnecessary treatments and side effects. This multi-center, prospective research includes both observational and randomized components to better manage early-stage CRC. The study has two parts Part B focuses on collecting tumor tissue, serial blood samples, and clinical data to detect minimal residual disease MRD using ctDNA after curative surgery. Part C is a randomized trial comparing ctDNA-guided adjuvant chemotherapy versus standard care in patients with high-risk stage II or III CRC. Patients are randomized post-surgery to either standard chemotherapy or a ctDNA-guided approach where those testing negative for ctDNA may receive less chemotherapy. Participants will undergo regular blood sampling and clinical assessments to monitor ctDNA levels and disease status. Researchers will measure outcomes such as 3-year disease-free survival and the relationship between ctDNA detection and treatment response over several years. The study includes follow-up periods of 4 to 8 years to evaluate long-term outcomes and safety. Participants need to consent, adhere to follow-up schedules, and be suitable for chemotherapy if randomized to Part C.

Age: 18Years +All Genders
71 locations