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An open-label, randomised, non-comparative phase 2 study evaluating S 95005 (TAS-102) plus bevacizumab and capecitabine plus bevacizumab in patients with previously untreated metastatic COlorectal cancer who are non-eligible for intensive therapy (TASCO1 study)

This study will evaluate 2 different treatment strategies : a combination of S 95005 and bevacizumab (experimental combination) and a combination of capecitabine and bevacizumab (control arm) as first-line treatment for metastatic colorectal cancer…

Pathogenic microbes: an exploration for their driving role in colitis associated cancer

To identify pathogenic bacterial biofilms in UC-patients with and without neoplasia in tandem with host factors such as barrier defects and carcinogenic pathway activation in a prospective cohort study.

89Zr-AMG211 PET imaging in patients with relapsed/refractory gastrointestinal adenocarcinoma before and during treatment with AMG 211.

Primary objective: To evaluate the in vivo biodistribution (measured in SUV) and quantitative radioactivity in organs of 89Zr-AMG211 in patients with relapse/refractory gastrointestinal adenocarcinoma as assessed by PET/CT. Secondary objectives: I)…

Needle based CLE in thoracic lymph nodes, a comparison with pathology.

To identify and define characteristics of healthy lymph nodes and lymph nodes involved in different pulmonal diseases (lungcancer and sarcoidosis)

neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination with Anastrozole to those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy with Abemaciclib in Combination with Anastrozole in Postmenopausal Women with Hormone Receptor Positive, HER2 Negative Breast Cancer

The primary objective of Study I3Y-MC-JPBY (JPBY) is to compare the biological activity ofabemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy byassessing the percentage change from the baseline value in…

18F-FDG PET/CT versus CT imaging in staging of primary Muscle Invasive Bladder Cancer

The purpose of this prospective study is to evaluate the value of 18F-FDG PET/CT and CT for preoperative regional N staging of bladder cancer and to verify the results by comparison with histopathological analysis, the gold standard.

Accuracy of detecting residual disease after neoadjuvant chemoradiotherapy for oesophageal cancer (PRESANO trial)

The aim of this present diagnostic study is to determine the accuracy by which we can detect residual disease after neoadjuvant chemoradiotherapy.

Phase 1-2 study of everolimus and low-dose oral cyclophosphamide in patients with metastatic renal cell cancer.

Primary: Phase I part 1) Assessment of the recommended dosing and schedule for metronomic cyclophosphamide when administered in combination with fixed dose (10 mg) oral everolimus in patients with mRCC with respect to the selective induction of CD4+…

Efficacy and safety of lanreotide Autogel® 120 mg administered every 14 days in well differentiated, metastatic or locally advanced, unresectable pancreatic or midgut neuroendocrine tumours having progressed radiologically while previously treated with lanreotide Autogel® 120 mg administered every 28 days.

Objectives:Primary:• To assess progression free survival (PFS) when treated with lanreotide Autogel® 120 mg administered every 14 days based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.0, and according to central review.Secondary:•…

A phase III prospective, two-cohort non-randomized, multi-centre, multinational, open label study to assess the safety of assisted- and self-administered subcutaneous trastuzumab as therapy in patients with operable Her2-positive early breast cancer.

The main purpose of this study is to determine the side effects of trastuzumab when it is given by each of these subcutaneous injection methods. The study will also gather information about whether and when the cancer comes back after taking…

Validation of optical frequency domain imaging (OFDI) bronchoscopy as a diagnostic imaging modality to characterize pulmonary lesions

To validate OFDI bronchoscopy as a diagnostic imaging modality to characterize pulmonary lesions.

Inguinal or Ilio-inguinal Lymphadenectomy for Patients With Metastatic Melanoma to Groin Lymph Nodes and no Evidence of Pelvic Disease on PET/CT Scan - A Randomised Phase III Trial (EAGLE FM)

This study aims to provide a more rational evidence base for appropriate management for metastatic melanoma in the groin LNs, through assessing the effect of the addition of ipsilateral pelvic lymphadenectomy on patient disease-free survival (DFS),…

A phase Ib, open-label, multi-center, dose escalation and expansion study of an orally administered combination of BKM120 plus MEK162 in adult patients with selected advanced solid tumors

Primary:To determine the MTD and/or RP2D of BKM120 and MEK162 in combination when administered orally to adult patients with selected advanced solid tumors. Secondary:• To characterize the safety and tolerability of the oral combination of BKM120…

Characterizing the bone marrow environment in advanced-stage myelofibrosis. A PET/MRI study.

Primary objectivesTo characterize the bone marrow microenvironment in advanced stage myelofibrosis (MF) before and during treatment with ruxolitinib, regarding osteoblastic activity, marrow fibrosis and - osteosclerosis and perfusion- and diffusion…

Creatine kinase, platelet aggregation, and bleeding risk in women with uterine leiomyomas

Main study:We want to assess whether bleeding risk in women with uterine leiomyomas is associated with CK activity and attenuated platelet aggregation.Objective of pilot study:Firstly, to perform a feasibility pilot of CK/AK measurement in menstrual…

A phase 1 Study to Evaluate the Safety and Feasibility of Intraoperative Detection of Clear Cell Renal Cell Carcinoma Using Indium-111-DOTA-girentuximab-IRDye800CW

To assess the feasibility and safety of intraoperative dual-modality imaging in patients with renal cell carcinoma with Indium-111-DOTA-girentuximab-IRDye800CW. Secondary objectives are to assess how intraoperative fluorescence imaging results…

Optimizing accelerometer data analysis to assess physical activity and sedentary behavior among breast cancer survivors: a laboratory study

1. To validate accelerometer cut-points to asses physical activity and sedentary behavior of breast cancer survivors. 2. To investigate the validity of accelerometers, inclinometers, heart rate and oxygen consumption to assess time spent in…

Ga-68-DOTA-RGD2 PET/CT in patients with head and neck cancer: a potential tracer to image angiogenesis in tumors.

The primary objective of the study is to ascertain the feasibility and safety to image tumor angiogenesis in head- and neck cancer patients using Ga-68-DOTA-RGD2 PET/CT. Secondary objectives are to determine the pharmacokinetics and biodistribution…

A multi-center, randomized open label study to assess the systemic exposure, efficacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC) (CLDK378A2112)

Primary: To assess the steady-state PK of 450 mg or 600 mg ceritinib taken daily with a low-fat meal as compared with that of 750 mg ceritinib taken daily in the fasted state in patients with metastatic ALK-positive NSCLC.Secondary: Overall response…

Dose-escalation by boosting radiation dose within the primary tumor on the basis of a pre-treatment FDG-PET-CT scan in stage IB, II and III NSCLC: A randomized phase II trial

The primary objective of this study is to determine the freedom from local failure in patients alive at 1 year