IMaging PAtients for Cancer Drug selecTion - Renal Cell Carcinoma (IMPACT-RCC)
Clear-cell Metastatic Renal Cell CarcinomaKidney NeoplasmsRationale. In part of the patients with good and intermediate risk metastatic renal cell carcinoma (mRCC) the disease course is indolent and immediate start of systemic therapy is not necessary. By now, the investigators are not able to identify those patients with indolent disease and the minor group of patients with rapidly progressive disease. In patients with indolent disease, a watchful waiting period is preferred, since their quality of life will not be unnecessary hampered by adverse events and therapy resistance is not induced. This study aims to identify those patients for whom a watchful waiting period is possible by molecular imaging. Furthermore several types of systemic therapy are possible once the progression is proven. These systemic treatments are comparable in terms of efficacy, but not in terms of toxicity and their impact on quality of life. As a secondary objective, the usefulness of a decision aid guiding the choice of the patients is studied. Objectives. To assess in patients with good or intermediate prognosis mRCC who are eligible for watchful waiting, the added value beyond clinical work-up of: FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict rapid progression (≤ 2 months after the baseline scan) under watchful waiting. FDG-PET and 89Zr-girentuximab-PET results measured at presentation to predict prolonged indolent (≥12 months after the baseline scan) disease under watchful waiting. To assess the value of a therapy choice decision aid for patients with progressive disease. Study design. This is a multicenter non-blinded prospective observational study in 80 good and intermediate prognosis mRCC patients. Study population. Patients with good or intermediate prognosis mRCC according to the Heng criteria, ≥18 years, without contra-indications for a watchful waiting period, able to provide informed consent. Intervention. At baseline an FDG-PET-CT and 89Zr-girentuximab-PET will be made. During the watchful waiting period, disease evaluation by CT according to the RECIST criteria will be made frequently, until established progressive disease. At that moment, a second FDG-PET-CT and, in case of a positive 89Zr-girentuximab-PET-scan at baseline, a second 89Zr-girentuximab-PET will be performed and the decision aid is used to help the patient to choose their best treatment out of four options; pazopanib, sunitinib, combined interferon-α with bevacizumab and (only in case of a positive 89Zr-girentuximab-PET) radioimmunotherapy (RIT) with 177lutetium labelled girentuximab. Participation in the RIT trial is part of a separate phase II study. Nature and extent of the burden and risks associated with participation, benefit and group relatedness. At baseline, a 18F-FDG-PET-CT and 89Zr-Girentuximab-PET will be performed. During the watchful waiting period CT's will be made. During therapy, follow-up will include standard laboratory analysis, and CT-scans on regular visits to the outpatient clinic. Side effects of the medication and adverse events as a consequence of the tumor biopsies may occur. The radiation exposure of both PET investigations is acceptable and requires no shielding after injection of 89Zr-labelled girentuximab. Patients may benefit from disease regression or stabilization. All three treatment choices has proven clinical benefit in this patient population. The risks of participation into the RIT trial are described in the phase II trial protocol, which already has been judged by the Medical Ethics Review Committee.
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
Stomach NeoplasmsColonic Neoplasms10 morePostoperative delirium(POD)is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. In order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. The efficiency and safety of neuroleptanalgesia on the incidence of POD would be evaluated in elderly patients.
Studying Genes Using Cord Blood and Placenta Samples From Relatively Healthy Newborns and Samples...
Kidney CancerRATIONALE: Studying samples of blood and tissue from newborns and from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research trial studies cord blood and placenta tissue from newborns, and tumor tissue samples from patients with Wilms tumor.
Renal Hypothermia During Partial Nephrectomy
Renal ImpairmentKidney Diseases4 moreThe Objective is to determine if renal hypothermia during open partial nephrectomy results in improved post-operative renal function compared to warm ischemia. Primary Aim is to determine the effect of hypothermia on preservation of overall renal function compared to no hypothermia in patients who require hilar vessel clamping during open partial nephrectomy for a renal tumor. Hypothesis: Hypothermia will result in improved post-operative preservation of overall renal function. Secondary Aim is to determine the effect of hypothermia on preservation of affected renal function (kidney with the tumor) compared to no hypothermia in patients who require hilar vessel clamping during open partial nephrectomy for a renal tumor. Hypothesis: Hypothermia will result in improved post-operative preservation of affected renal function.
Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer
Kidney CancerMetastatic CancerRATIONALE: Diagnostic procedures, such as contrast-enhanced ultrasound, may help measure a patient's response to treatment with drugs such as sunitinib malate, sorafenib tosylate, or bevacizumab, and allow doctors to plan better treatment. PURPOSE: This clinical trial is studying ultrasonography in assessing antiangiogenic treatment in patients with advanced kidney cancer.
Study In Patients With Kidney Cancer Treated With Sutent
Advanced or Metastatic Renal Cell CarcinomaRenal CancerObjective of this study is to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of sunitinib.
Biomarkers in Patients With Kidney Cancer or Cancer of the Urothelium and in Healthy Participants...
Bladder CancerKidney Cancer2 moreRATIONALE: Studying samples of blood and urine from patients with cancer and from healthy participants in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This laboratory study is looking at biomarkers in patients with kidney cancer or cancer of the urothelium and in healthy participants.
Genetic Study to Identify Gene Mutations in Participants Previously Enrolled in Clinical Trial NCI-99-C-0053...
Kidney CancerVon Hippel-lindau SyndromeRATIONALE: The identification of gene mutations in individuals who have or are at risk for von Hippel-Lindau syndrome may allow doctors to better determine the genetic processes involved in the development of cancer. PURPOSE: This genetic study is finding gene mutations in participants with von Hippel-Lindau syndrome or who are at risk for developing von Hippel-Lindau syndrome.
DNA Variations in the Gene in Young Patients With Wilms' Tumor
Kidney CancerRATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at DNA variations in the RASSF1A gene in young patients with Wilms' tumor.
Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data...
Kidney NeoplasmsThe objectives of this study is to investigate treatment patterns and outcomes for Sutent and Inlyta in mRCC patients in a nationwide population-based setting in Sweden.