View clinical trials related to Kidney Neoplasms.
Filter by:Nephroblastoma (Wilms tumor, WT) is the most common renal tumor of childhood representing ± 6% of all childhood malignancies. The diagnosis is established on clinical and radiological grounds. Metastases are visible on conventional imaging in at least 12% of nephroblastoma patients; however, an additional ~15% of patients have nodules on CT-scan only. The treatment consists of neoadjuvant (preoperative) chemotherapy, nephrectomy and risk-based adjuvant chemotherapy ± radiation therapy (RT) to the flank and/or metastases. For truly localized tumors, overall survival is > 85% (high risk histology excluded). Several high risk biological characteristics have been identified: diffuse anaplasia, gain of 1q chromosome, loss of heterozygosity 1p + 16q, blastemal residual volume. For metastatic nephroblastoma, the standard neo-adjuvant chemotherapy includes 3 drugs: vincristine, actinomycin-D and doxorubicin (VAD). Long-term survival is 82% (1). However, two issues arise. First, the use of doxorubicin ± concomitant RT might be associated with cardiac and pulmonary sequelae (4-17% of congestive heart failure) (2), and actinomycin-D is associated with hepatic toxicity (3). Second, patients with "CT-only" nodules are treated according to "localized disease". However, their outcome is poorer than that of truly "localized disease" (4-6). The efficacy of carboplatin and etoposide is known for a long time; these drugs are used as second line treatment or for high-risk histology nephroblastoma. Therefore, an alternate chemotherapy has been designed that combines drugs shown as highly efficacious in nephroblastoma, i.e., Vincristine, Carboplatin and Etoposide (VCE). VCE has been used for the treatment of other pediatric malignancies. For metastatic nephroblastoma, the switch from VAD to VCE and the associated reduction of actinomycin-D and doxorubicin is expected to reduce the chemotherapy-related long-term toxicity. In addition, VCE could potentially decrease the rate of patients requiring pulmonary RT. Finally VCE may have a beneficial effect on tumor high risk biological characteristics. French patients with nephroblastoma have been treated for > 40 years according to SIOP protocols collaborating in the SIOP Renal Tumour Study Group (SIOP-RTSG). This group has designed an international randomized phase III clinical trial for the evaluation of VCE versus VAD in patients with metastatic renal tumors (>>90% having nephroblastoma), in order to decrease the long-term toxicity while at least preserving, if not improving, the treatment efficacy. In addition, the issue of "CT-only" nodules and their adequate treatment needs to be solved. In previous protocols, the treatment strategy was based on the diagnosis of pulmonary metastases (~90% of all metastases) by conventional pulmonary X-ray. Central Radiological Review (CRR) is planned for the initial staging using CT ± MRI, as it is expected to more accurately detect patients with metastatic disease, including patients with "CT-only" nodules. In addition, CRR will be set up for real-time response assessment during treatment, in order to reliably determine who require pulmonary RT and which postoperative chemotherapy. Therefore, the main trial objectives are: - Explore the non-inferiority (efficacy) of neoadjuvant VCE chemotherapy (experimental arm) as compared to the standard arm with VAD. - Provide central radiological review (CRR) at diagnosis and after neoadjuvant chemotherapy in order to determine more precisely the appropriate treatment for each patient. The primary objective of the RCT is to investigate the metastatic complete response rate (MetCR, including very good partial response (VGPR)) of neoadjuvant 6 weeks of VAD as compared to neoadjuvant VCE in stage IV renal tumours using CRR. Several international studies have shown that MetCR is a good surrogate endpoint for survival. The postoperative treatment, secondary objectives as well as the intended methodology are detailed in the research project. The total number of patients is 406 patients for the entire phase III trial running in the 12 major SIOP countries (max 110 patients in France). The expected trial duration is 5 years for accrual + 2 years follow-up (the overall 10-year follow-up for long-term toxicity will be an independently funded ancillary study. This duration is required for a reliable evaluation of the cardiac toxicity). The results of the current trial should be useful for the future protocols for the treatment of all patients with nephroblastoma (metastatic but also localized and bilateral). The results of this RCT will be worthy for the entire international pediatric oncology community and future patients throughout the world and will be communicated in scientific congresses and high-level peer-reviewed journals.
NiSAR is a Ph.D. study and consists of three substudies. Renal cancer is one of the most deadly urologic malignancies and accounts for 900 new cases and 300 deaths per year. An increase in the use of imaging diagnostics has yielded a rise in the incidental detection of small renal masses (SRM), meaning tumors <4cm (T1a). Kidney biopsies are the gold standard for diagnosing SRM but has an inherent risk of infections, retroperitoneal bleeding and in rare cases loss of kidney function. This is problematic since up to 30% of SRM are benign. This Ph.D. consists of three studies that all aim to develop new minimally invasive modalities for diagnosing SRM. Patients eligible for these studies are diagnosed with SRM at one of the departments of Urology in the southern region of Denmark. Studies 1 and 2 aims to find circulating biomarkers, in the form of DNA and messenger ribonucleic acid (mRNA) contained in micro vesicles secreted into blood by renal cell cancers and find changes in biomarkers levels after surgery. Study 3 aim to determine the potential of multiplanar MRI (mpMRI) to discriminate between benign and malign SRM. Potentially this can lead to a fundamental change of the way urologists diagnose and monitor SRM and renal cell cancer in general. The investigators will also build a research biobank for future research.
A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic partial nephrectomy) and improved patient care.
Patients with non-surgical or renal cell carcinoma that has spread who are starting treatment for the first time with Yervoy and Opdivo in the real world
The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.
The diagnosis and treatment trajectory of cancer can constitute a traumatic event because these can be perceived as sudden, catastrophic and life threatening. One common mental disorder following traumatic events is post-traumatic stress disorder (PTSD), described as reexperiencing of the event (e.g., having intrusive thoughts), having avoidance of trauma memories, emotional numbing, and experiencing hyperarousal symptoms. To date, and to the best of the investigator's knowledge, few studies have focused on PTSD in advanced cancer, but the existing data show that these patients are at risk for experiencing PTSD symptoms. Among the early interventions for preventing PTSD in people confronted by traumatic events is group debriefing, the retelling of the event, receiving empathy and compassion, and being encouraged to express feelings. However, four meta-analyses found debriefing to be ineffective. A neuroscience-based and evidence-based alternative may be the Memory Structuring Intervention (MSI) that tries to shift trauma processing from a limbic, emotional and somatic level to a frontal-cortical, cognitive and verbal level of processing. The MSI tries to achieve this shift by teaching people confronted with traumatic events to chronologically organize the segments of the event, to verbally label feelings or somatic sensations rather than re-experience them, and to provide causal links between the event's segments and causality to their feelings and sensations Since in males, sympathetic responses were more predictive of PTSD than in females , parasympathetic activation may be needed to be added to the MSI, for men. A main branch of the parasympathetic response is the vagus nerve, whose non-invasive index is Heart Rate Variability (HRV). One way to increase HRV, and thus parasympathetic activation, is through vagal breathing (i.e., deep, paced breathing). Therefore, adding to the MSI deep vagal breathing (VB) to reduce sympathetic hyperactivity, may increase connectivity between the amygdala and the frontal cortex. This may also increase the emotional regulation possibly yielded by the MSI, however in both genders. The effects of the MSI + vagal breathing on PTSD symptoms and on prognosis in advanced cancer patients receiving announcement of terminal cancer have never been investigated. Furthermore, whether reduced inflammation and increased emotional regulation may account for such effects needs to be investigated at the fundamental level. This project reflects the merging of neuroscience, psychooncology and psychoneuroimmunology for better understanding and treating cancer patients, as well as their partners.
This is a single arm, open-label, uni-center, phase I-II study to evaluate the safety and effectiveness of CAR-T/TCR-T cell immunotherapy in treating with different malignancies patients.
This is an open-label Phase 2 study which will evaluate the efficacy and safety of belzutifan in combination with cabozantinib in participants with advanced ccRCC. Belzutifan and cabozantinib will be administered orally once daily.
Generally, in the trials, an observant patient is described as correctly taking 90 to 100% of the prescribed doses. Here, the 80% compliance rate will be the cut-off between observant and non-observant patients. The evaluation methodology is based primarily on a survey of patients with metastatic or locally advanced kidney cancer who have just began an oral treatment protocol. The constitution of this cohort will be made from newly treated patients included by oncologists. The survey consists of implementing a series of questionnaires with each patient of the sample throughout the course of oral cancer care. This series of questionnaires will aim to identify: - the gradient of compliance of the patient with his treatment, - all the factors likely to influence positively or negatively the latter, whether medical, material or socio-economic, - the evolution of patient compliance during their treatment course, - a patient's quality of life index through the standardized quality of life survey form (EORTC - Quality of Life Questionnaire QLQ C30 version 3). - These questionnaires will be supplemented by the medical record data (including information on tolerance and possible drug interactions). The representativeness of the patients surveyed will be established by comparing the statistical characteristics of the surveyed population with those of the aggregate anonymous global data obtained by the two Medical Department of the French Regional Health Insurance of the two regions. From the data compiled by this study, different econometric models of patient behavior will seek to establish, in particular, a relationship between the probability that a given patient will be either non or poorly observant and the various variables proved to be statistically significant.
The BIOREN project aims are to characterize the genetic background of renal cell carcinomas and their immune environment, to try and identify biomarkers of response and to better understand the mechanisms of resistance to nivolumab in renal cancer.