View clinical trials related to Neoplasms.
Filter by:The primary goal of the population-based colorectal (CRC) screening is early detection and interception of CRC and its precursors to decrease CRC-related morbidity and mortality. To improve current CRC screening programs, the investigators have developed and retrospectively validated a test that combines the detection of multiple proteins in stool (the multitarget faecal immunochemical test, mtFIT). mtFIT was found to have a higher accuracy to detect advanced neoplasia (AN), which includes CRC, advanced adenomas and advanced serrated polyps, in comparison to FIT. Thus, this multitarget test has the potential to improve the screening program's efficiency in reducing CRC-related incidence, morbidity and mortality. This new test, in comparison to FIT, shows specifically higher sensitivity in the detection of advanced adenomas, without affecting specificity.
In this randomized-controlled two-arm monocentric study with three measurement time points, the effectiveness and feasibility of an internet-based, therapist-guided mind-body self-help intervention for gynecological cancer patients with primary diagnoses is examined. Different modules (e.g., relaxation, mindfulness, stress management, disease management, nutrition and exercise behaviors) with a mind-body focus are available for the patients. The goal of the intervention is to improve or maintain the quality of life.
This is a phase Ia/Ib open, multicenter study of solid tumor subjects in China.Including dose increasing period and cohort expansion period.A BOIN design is used in the dose escalation phase,a total of 8 dose groups were designed.In the expansion phase of the cohort, 15 to 30 subjects will be enrolled in a specific tumor type (liver cancer, stomach cancer, kidney cancer, melanoma, urothelial carcinoma, and other tumors determined by the SMC).
To assess safety and tolerability of increasing doses of IO-202 either as monotherapy or in combination with pembrolizumab in patients with advanced solid tumors, and select the recommended Phase 2 dose (RP2D).
Meso-Immune is a retrospective study to assess the efficacy and safety of the combination of Nivolumab and Ipilimumab used in first-line treatment of adult patients with unresectable Malignant Pleural Mesothelioma (MPM). This combination of treatments has been approved in Europe since June 2021 based on the results of the CheckMate 743 study. In France, the combination is not yet reimbursed for this population of patients. However, since April 01, 2021, newly diagnosed unresectable MPM patients may be treated with this combination via an early access program. Meso-Immune study targets these patients included in the early access program with the objective to provide additional results to the CheckMate 743 study and confirm the benefit of using this combination in first-line of treatment in this category of patients. Total study duration will cover 48 months with an inclusion period of 12 months and a follow-up until 3 years. Patients will be recruited retrospectively starting April 01, 2021 until April 01, 2022. Meso-Immune study will be proposed to all the GFPC centers that have already included patients in the early access program and other centers wishing to participate, in order to analyze a minimum of 150 patients. The total number of sites is evaluated at around 120. The principal investigator in each center will identify the patients eligible for the Meso-Immune study and will inform them on the study according to the local regulations. Patient follow-up will be pursued regularly, in in-patient and out-patient clinics, according to the usual practices of the physicians in each participating center. Reevaluation workups will be pursued according to the practices of each center. The information related to Patient characteristics, MPM characteristics, Treatment characteristics, Disease progression, Rebiopsy, Post treatments, Adverse events, Date and cause of death, Date of last news will be recorded in electronic case-report forms (eCRF). Qualitative variables will be presented descriptively in the principal analysis.
Pediatric epidural anesthesia has emerged as a safe and effective regional anesthesia technique for providing intraoperative and postoperative analgesia in thoracic and abdominal surgery. The loss of resistance technique is the gold standard for the placement of the epidural. The VPC (visual pressure control) syringes developed by PAJUNK enable direct visualization of the introduction of the needle into the epidural space.
This is a phase I/IIa, two-part, open-label study to characterize the safety, tolerability, pharmacodynamics, and antitumor activity of ICT01 in combination with LDSC IL-2 in patients with advanced-stage solid tumors. Part 1 will be a dose escalation of IV ICT01 administered on the first day of every 21-day cycle (CnD1) to patients with advanced-stage solid tumors in combination with LDSC IL-2 (Proleukin®) administered daily on days 1-5 of cycles 1-3 (C1-3D1-5). Objectives of part 1 are to characterize the safety of the combination regimen and determine the RP2D for Part 2. Part 2 will comprise a maximum of 2 indications and 2 combination dosing regimens of ICT01 +LDSC IL-2, which will be supported by statistical power calculations once the indications are selected. The final regimen will be ICT01 + LDSC IL-2 + Pembrolizumab on a Q3W cycle. The primary objective of Part 2 is to demonstrate the efficacy of the combination regimen based on RECIST1.1 in one or more solid tumor indications.
Muscle mass loss is a common adverse effect of cancer. Muscle mass loss occurs with or without reduction in body weight. Cancer cachexia (CC) is the involuntary loss of body weight of >5% within 6 months and it occurs in 50-80% of patients with metastatic cancer. It is estimated that CC is a direct cause of up to 30% of all cancer-related deaths. No treatment currently is available to prevent CC, likely because the chemical reactions that causes of this devastating phenomenon in unknown. No treatment currently is available to prevent muscle mass loss in patients with cancer but is urgently needed as the reduced muscle mass and function is associated with impaired physical function, reduced tolerance to anticancer therapy, poor quality of life (QoL), and reduced survival. There is evidence of an interdependence between informal caregiver (e.g. spouse) and patient QoL. Thus, identifying caregiver distress and needs can potentially benefit QoL for patients with cancer cachexia. Despite the enormous impact on disease outcomes, it is not known why the loss of muscle mass and function occurs and very few studies have investigated the underlying molecular causes in humans. In particular, there is a severe lack of studies that have obtained human skeletal muscle and adipose tissue sample material. Such reference sample materials will be invaluable to obtaining in-depth molecular information about the underlying molecular causes of the involuntary but common muscle mass and fat mass loss in cancer. At a whole body level, cancer cachexia is associated with reduced sensitivity to the hormone insulin, high levels of lipids in the blood, and inflammation. Within the skeletal muscle, the muscle mass loss is associated with elevated protein breakdown and reduced protein build-up while emerging, yet, limited data also suggest malfunction of the power plants of the cells called mitochondrions. The role of malnutrition and how it contributes to weight loss is understood only to the extent of the observed loss of appetite and the reduced food intake because of pain, nausea, candidiasis of the mouth, and breathlessness. Evidence is increasing that the environment of the intestinal system could be implicated in cancer cachexia, yet, the possible effect of cancer and the cancer treatment on the intestinal environment is not understood. Thus, large and as yet poorly understood details of this syndrome precede a later weight loss. Exercise training could help restore muscle function and how the chemical reactions works in cancer. In healthy people, and patients with diabetes, cardiovascular disease, and obesity exercise potently improves health. Exercise has been thought to slow down the unwanted effects of cancer cachexia by changing the reactions mentioned above. Thus, there is a tremendous gap in our knowledge of how and if exercise can restore the cells power plants function, muscle mass, strength, and hormone sensitivity in human cachexic skeletal muscle. Tackling that problem and examining potential mechanisms, will enable us to harness the benefits of exercise for optimizing the treatment of patients with cancer. The data will provide novel clinical knowledge on cachexia in cancer and therefore addressing a fundamental societal problem. Three specific aims will be addressed in corresponding work packages (WPs): - investigate the involvement of hormone sensitivity of insulin and measure the chemical reactions between the cells in patients with lung cancer (NSCLC) and describe the physical performance and measure amount of e.g. muscles and adipose tissue across the 1st type of cancer treatment and understand how that is related to the disease and how patients and informal caregiver feel (WP1). - find changes in the chemical reactions in skeletal muscle, adipose tissue (AT), and blood samples in these patients, to understand how to predict how the disease will develop (WP2). - measure changes of skeletal muscle tissue in response to exercise and see if it might reverse the hormone insensitivity and improve muscle signaling and function (WP3). The investigators believe that: - the majority of patients with advanced lung cancer, at the time of diagnosis already are in a cachectic state, where they lose appetite, and have hormonal changes, and an overall altered chemical actions between the cells affecting both muscle mass and AT. The investigators propose that all this can predict how the disease will progress, and how patient- and informal caregiver fell and how they rate their quality of life. - lung cancer and the treatment thereof is linked with changes in the blood, the muscle tissues, and the adipose tissues, especially in patients experiencing cachexia, that could be targeted to develop new treatment. - exercise can restore the muscles and improve insulin sensitivity and improve the function of the cells power plants in patients with lung cancer-associated muscle problems.
Study to evaluate the safety and tolerability of the study drug CLN-418, to determine the maximum tolerated dose and/or recommended Phase 2 study dose of CLN-418.
MRI is a well-established method in breast imaging. It gives excellent morphological information but does not reflect the metabolic activity leading to high proportion of false positive results. PET-CT fulfills this gap but suffers from low resolution and the risk of radiation damage. Lately, chemical exchange saturation transfer (CEST) MRI of glucose has been proposed as a new molecular imaging approach for diagnosing tumors given its high sensitivity at the molecular level and the known enhanced glucose uptake by tumors. Several glucose analogs were examined as possible candidates for imaging of breast tumors. One of the most promising agent for CEST-MRI is glucosamine (GlcN); owing to its phosphorylated products that accumulate in breast tumors, it enables to reflect their metabolic profile. In preclinical experiments glucosamine exhibits enhanced CEST signals in 4T1 and MCF7 implanted breast cancer cells in mice. Its potential for the human clinical application is strengthened by its lack of toxicity. Here the investigators propose to test the method for human subjects on a clinical MRI setup. The goal of this study is to develop innovative molecular imaging modality based on CEST-MRI of GlcN for the detection of breast tumors. The investigators will use the newly developed CEST-MRI modality for the detection of benign and malignant breast cancer in a clinical MRI scanner. .