There are about 25560 clinical studies being (or have been) conducted in Germany. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Active Surveillance (AS) is a treatment option in patients with favorable risk prostate cancer. According to the current guidelines patients are monitored by prostate specific antigen (PSA) testing (every 3 months) and regular re-biopsies. Due to histological reclassification and/or patient noncompliance a high number of patients discontinue AS. Nonetheless, because of an increasing number of diagnosed early stage tumors overdiagnosis and overtreatment of patients has become a major clinical problem. Therefore AS is a promising and important tool for patients with low and intermediate risk prostate cancer. Multiparametric MRI (mp-MRI) in combination with radiomics analysis, MR-guided biopsies, and molecular markers are promising tools to optimize patient selection and observation during AS. This prospective, single arm, multicenter phase II study evaluates mp-MRI, radiomics, MR-guided biopsies and molecular markers for AS with the primary endpoint of reducing discontinuation based on histologic reclassification. At the end of this study the results may allow defining a MRI-based pathway to identify and monitor patients suitable for AS supported by radiomics. Thus, the high rate of discontinuation due to misclassification at initial diagnosis will be reduced. Additionally, this strategy will allow reducing over-treatment of clinically insignificant PCA, and on the other hand, increasing early treatment of higher-risk disease. Monitoring by mp-MRI will reduce the number of prostate biopsies and cores per patient during AS, and thus increase the patient compliance. Finally, such a strategy will reduce the economic burden of treating insignificant prostate cancer.
Men diagnosed with metabolic syndrome (MetS) including obesity, hypertension, dyslipidemia and infertility will be assessed for cardiovascular and diabetes risk. The eligible patient will be randomised to one-year life-style intervention program including nutritional, behavioural and exercise counselling or standard care by the general physician. The aim of the program is to reduce cardiovascular and diabetes risks and hypogonadism as well.
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.
Oral squamous cell carcinomas (OSCC) is among the most common malignancies worldwide. Early detection and prevention of OSCC is thought to have the highest potential to reduce morbidity and mortality. In prevention, the main focus is on precancerous lesions, especially oral leukoplakia (OLP), as up to 67% of OSCC arise on the basis of OLP. The determination of the transformation risk of OLP by histological determination of the degree of dysplasia is unreliable. A promising marker for the timely development of a OSCC is the detection of antigens of the MAGE-A gene family. The special feature of MAGE-A is that they can be detected in 93% of all OSCC and in approx. 85% of OLP that transform to OSCC. The detection of MAGE-A could also indicate changes in the immunological environment that occur prior to malignant OLP transformation and could be used for immunotherapies. Aim of this study is to investigate MAGE-A as a predictive marker for the malignant transformation of OLP in the setting of a prospective, multicenter study and to establish it as a diagnostic parameter in addition to classical histology. In addition, the association of MAGE-A expression with the occurrence of immunological changes in OLP will be investigated in order to evaluate the possibility of minimally invasive immunotherapy of OLP. The study is intended to include 500 biopsies of non-selected patients with OLP from university institutions and private practices. The follow-up should be at least 3 years, whereby it is examined whether an OSCC on the basis of the original OLP developed. After three years, an interim evaluation of the results with statistical evaluation will be carried out. In order to ensure that the course of the disease is monitored for at least three years for all OLPs, an extension of the monitoring period to 5 years is planned. The study could establish a routine diagnostic parameter to supplement the histo-morphological diagnosis of OLP and evaluate the possibility of immunotherapy of OLP.
Correct measurement of the intraocular pressure of children with glaucoma or suspected glaucoma is essential for diagnosis and therapy. Despite new non-invasive measurement methods most of the children are uncooperative during the ophthalmological examination. Therefore examination under anaesthesia is needed. A lot of perioperative factors influence the measurement of intraocular pressure. Established and safe anaesthetic regimes have been modified regarding these factors. Aim of the study is to evaluate, if a standardized anaesthetic protocol generates reliable and reproducible measured values.
Study design Prospective multicentre explorative randomized single blinded study to evaluate accuracy of molecular genetic characterisation of NSCLC. Patients with suspected lung cancer are randomized in a 1:1-setting for bronchoscopic tumor tissue either by forceps or by cryobiopsy. Apart from the bronchoscopic techniques liquid biopsy of peripheral blood and if feasible transbronchial needle aspiration with or without endobronchial ultrasound guidance are performed for in all patients. Objectives Primary Objective: assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy Secondary Objective: assessment of differences in detection of molecular genetic alterations in NSCLC between - liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA - combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques - naïve and processed tumor tissue specimen (eg. microdissection) To assess differences in side effects e.g. periinterventional bleeding Explorative Objective: To explore tumor mutational burden with regard to - solid tumor tissue by bronchoscopic forceps biopsy by bronchoscopic cryobiopsy - cytologic material by (EBUS-guided) TBNA - liquid biopsy Target subject population Patients with suspected lung cancer or proven NSCLC and visible tumor suspicious lesion(s) requiring tissue diagnosis form the study population of this trial.
Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.
This study evaluates a protocol for regional citrate anticoagulation in critically ill patients with acute kidney injury who are treated with continuous veno-venous haemofiltration in postdilution mode.
Assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in pediatric subjects between ≥ 2 to < 18 years of age, with chronic kidney disease (CKD) on hemodialysis