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NCT ID: NCT03310879 Not yet recruiting - Cancer Clinical Trials

A Phase II Study of the CDK4/6 Inhibitor Abemaciclib in Patients With Solid Tumors Harboring Genetic Alterations in Genes Encoding D-type Cyclins or Amplification of CDK4 or CDK6

Start date: October 31, 2017
Phase: Phase 2
Study type: Interventional

This research study is studying a targeted therapy as a possible treatment for cancer abnormality in one of the following genes: CCND1, CCND2, CCND3, CDK4, or CDK6. The drug involved in this study is: -Abemaciclib

NCT ID: NCT03308773 Enrolling by invitation - Cancer Clinical Trials

Disease Prevention in Clinical Practice Base on Patient Specific Physiology

STOPDISEASE
Start date: January 5, 2009
Phase: N/A
Study type: Observational

It is well known that the Type 2 diabetes and vascular disease are preceded by over ten years by metabolic dysfunction and anatomic changes that can be quantified. In order to develop effective preventive strategies and reduce the cost burden to the health care system, recognition of the earliest pathophysiology of Type 2 diabetes and vascular disease is clinically relevant. The interval retrospective evaluation of data from patient records, reflect the effectiveness of the various treatments implemented in clinical practice. Prevalence of "prediabetes" among American adults is estimated to be ~84 million, or one out of three Americans. Over a 5-7 year period approximately one third of these prediabetic individuals will progress to type 2 diabetes. Prediabetes is a heterogenous group comprised of individuals with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and increased A1c (5.7-6.4%). Although different pathophysiologies are present in individuals with IFG and IGT, their conversion rate to overt type 2 diabetes mellitus (T2DM) is similar. Insulin resistance is a common causal feature of many of the pathophysiologic mechanisms linking macrovascular disease and type 2 diabetes. Because hyperglycemia is the major factor responsible for the development of microvascular complications, it logically follows that prevention of progression of prediabetes to overt diabetes should retard/prevent the development of the microvascular complications. From the measurement of plasma glucose, insulin, and c-peptide levels during the oral glucose tolerance test, one can derive measures of the two core defects responsible for the development of T2DM, i.e. insulin resistance and beta cell dysfunction as well as the degree of dysglycemia. By combining a standard medical evaluation with the evaluation of cardiovascular biomarkers, patients at intermediate risk of vascular disease can be identified. In these patients, carotid intima media thickness (IMT) and carotid plaque evaluation is offered to attempt to clarify risk. The hypothesis of this observational study is that the characterization of the physiology and anatomy of patients at risk of developing type 2 diabetes and/or cardiovascular disease can stratify risk of developing disease and direct treatment strategies tailored to the identified physiologic defect, leading to improvements in the delay or prevention of disease.

NCT ID: NCT03307629 Not yet recruiting - Cancer Clinical Trials

Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer

Start date: November 1, 2017
Phase: Phase 1
Study type: Interventional

The study is intended as a Proof of Concept and dose confirmation study. The primary objective of this study is to observe safety and tolerability of idronoxil (NOX66) in combination with radiotherapy (at palliative doses) in patients with metastatic castrate-resistant prostate cancer (CRPC) and to confirm dose in order to progress to Phase 2/3.

NCT ID: NCT03305965 Enrolling by invitation - Cancer Clinical Trials

The Effectiveness of Patient Navigation in Cancer Care

Start date: October 15, 2016
Phase: N/A
Study type: Interventional

Rationale: Supportive care such as physical therapy, psycho-social education, and dietary advice is likely to have a positive effect on the recovery and quality of life of cancer patients. Currently, not all patients know how to access supportive care, which results in unmet supportive care needs. This study determines whether these unmet needs can be reduced or prevented by a patient navigation intervention that focuses on timely screening and systematic monitoring of patient's supportive care needs. Objective: The primary objective is to determine the effect of patient navigation on health related quality of life. Secondary objectives are: 1) to determine the effect of patient navigation on satisfaction with, need for, and consumption of (supportive) cancer care; 2) to determine the effect of patient navigation on patients' self-management; 3) to explore how patient navigation affects the cost-effectiveness of cancer care. Study design: Longitudinal randomised controlled trial with two study arms: a patient navigation intervention and care as usual. Study population: Newly diagnosed lung, melanoma, urology, or gynecology patients of the Netherlands Cancer Institute. Intervention : Consultations with a specifically trained oncology nurse (i.e. patient navigator), who assesses patients' needs for supportive cancer care, provides information on supportive cancer care, and guides patients through the supportive cancer care system. Consultations with the patient navigator take place at the start, halfway through, and at the end of treatment. Main study endpoints: The main endpoint of this study is health related quality of life, which is defined as an individual's perceived emotional, social, physical, and functional wellbeing over time. Health related quality of life is assessed with the EORTC QLQ-C30. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants are expected to strongly benefit from consulting the patient navigator without being subjected to any severe risks. Consultations will be provided by highly qualified professionals, and result in benefits such as decreased severity of cancer-related psychosocial and physical distress. To minimise burden, face-to-face consultations will always be scheduled alongside other appointments of at the NKI-AVL. Furthermore, questionnaire completion takes no more than 30 minutes per data collection round, of which three are scheduled in this study.

NCT ID: NCT03304990 Recruiting - Cancer Clinical Trials

Panomics Relationships in the Epidemiology of Cancer Through In Silico Expression (PRECISE)

Start date: September 26, 2017
Phase: N/A
Study type: Observational [Patient Registry]

PRECISE is a study to discover new detection, prognosis and treatment biomarkers for cancer. This is a prospective, multi-center, observational study designed to collect de-identified biospecimens and clinical data from a large cohort of participants from clinical research networks in the United States. In this study, the investigators propose creating a large-scale normalized panomics dataset specifically designed for deep learning-based in silico analysis for biomarker discovery.

NCT ID: NCT03302767 Recruiting - Cancer Clinical Trials

CAP'Onco : Psychological and Social Consultation of Professional Accompaniment in Oncology

CAP'ONCO
Start date: August 7, 2017
Phase: N/A
Study type: Interventional

This patient support system is designed to help patients regain their professional activity after their treatment. It's a 3-Axis neuropsycho-social synergy on 3 axes: - A weekly pluridisciplinary consultation in tandem (Social worker + Psychologist / Neuropsychologist) - Monthly information meetings and workshops (TIC'Onco reunions: collective information times and Cogit'Onco workshops: cognitive workshops - An information booklet "Prepare the work return" The aim of this research is to evaluate efficiency in term of quality of life improvement linked to work status, utility, feasibility and patients' satisfaction. The aim of this research is to evaluate efficiency in term of quality of life improvement linked to work status, utility, feasibility and patients' satisfaction.

NCT ID: NCT03300102 Not yet recruiting - Cancer Clinical Trials

Acceptability and Feasibility Study of Patient-specific 'Tumouroids' as Personalised Treatment Screening Tools

Tumouroids
Start date: October 31, 2017
Phase: N/A
Study type: Observational

In England, more than three hundred thousand people are diagnosed with cancer each year. The diagnostic and treatment pathways for multiple cancers have greatly developed over the past decade. However, novel treatments are expensive and currently discrimination between responders and non-responders is still suboptimal. There is a pressing need to develop tools that allow for better disease characterisation and stratification. Personalised medicine, whereby prevention, diagnosis, and treatment of diseases is aimed at the individual level, is a growing field. Predicting patient-specific treatment response is challenging as response depends not only on the characteristics of cancer cells but also on how these cells interact with their immediate surrounding environment and on how the tumour interacts with the host. A simplistic model is therefore insufficient to predict treatment response. Complex, patient-derived animal models have been used to this effect but are expensive, may take up to 6 months to provide clinically relevant answers, and pose ethical issues. In the past in vitro models lacked complexity as they were based solely on the two-dimensional (2D) growth of cancer cells. Nowadays the use of 3D tumour models has provided an extra level of complexity to in vitro studies. With these models it is possible to recreate tumour characteristics that were lost in 2D, such as cell-cell interaction between cancer cells and between cancer and stromal cells, cell-matrix interaction, or hypoxia. The investigators have developed a 3D complex tumour model - named tumouroid. Using this model, preliminary work has been undertaken which allows the growth of patient-derived tumouroids using primary cancer cells from patients. This personalised platform can be challenged by therapeutics used in clinical practice and response to treatment can be assessed via appropriate assays. The study goals are twofold: To assess patient acceptability to the use of patient derived tumour models for future decision-making, and To assess the feasibility of generating patient derived renal cancer tumouroids and using them as platforms to test drug response.

NCT ID: NCT03299465 Not yet recruiting - Cancer Clinical Trials

Yoga for Fatigue in the Survivors of Bone Marrow Transplantation

Start date: October 2017
Phase: N/A
Study type: Interventional

Cancer-related fatigue (CRF) after hematopoietic cell transplantation (HCT) is a persistent problem that limits activities and causes distress. Considering the high prevalence of CRF among HCT survivors and the limitations of currently existing treatments, there is a pressing need for establishing safe and effective options for reducing CRF after HCT. Based on evidence supporting the use of yoga for CRF in non-HCT populations, yoga is one option worthy of evaluation for ameliorating CRF in HCT patients. Yoga is easy to implement, may be appealing to HCT patients, and can be self-administered, which would encourage long-term use and potentially lead to a better control of persistent CRF in HCT survivors. The primary aim of the proposed study is to assess the feasibility of a yoga intervention for HCT survivors with CRF. Outcomes from this feasibility study will provide the information needed to design a larger, adequately powered randomized controlled trial to evaluate yoga for CRF in HCT survivors. This study will employ a mixed-methods, single-arm, pretest-posttest design with focus groups. Twenty HCT survivors who report at least moderate fatigue will be recruited from the HCT clinic, Michigan Medicine. Participants will be enrolled in a six-week Restorative yoga program. The program will consist of a weekly, 60-minute yoga group class led by a certified yoga instructor along with twice-weekly home practice using yoga DVD.

NCT ID: NCT03297359 Not yet recruiting - Obesity Clinical Trials

WAVe Study - Weight Adjusted Dalteparin for Patients Over 90 kg With Acute Cancer Associated Venous Thromboembolism

WAVe
Start date: January 1, 2018
Phase: Phase 2
Study type: Interventional

Cancer patients that develop blood clots are treated with low molecular weight heparin injections (LMWH). One kind of these LMWHs, dalteparin, has its dose determined based on a patient's weight using a formula of 200 international units (IU) per kilogram (kg). The current dosing of dalteparin approved by Health Canada has a maximum daily dose of 18 000 IU/day which is weight-adjusted for patients up to 90 kg. Any patient weighing more than 90 kg would take the same dosage regardless of their weight. The aim of this study is to assess the safety of using weight-adjusted dalteparin in cancer-associated venous thromboembolism patients that weigh more than 90 kg.

NCT ID: NCT03296150 Not yet recruiting - Cancer Clinical Trials

ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE

ADOPT-PRESTAGE
Start date: October 2017
Phase: N/A
Study type: Interventional

As the proportion of oral anticancer treatments is continuously increasing, adherence appears as a major issue for patients' outcomes. Poor adherence affects particularly geriatric patients due among others to polypharmacy or cognitive impairment. Thus, the need for educational programs in this population has been regularly emphasized. PRESTAGE educational program was built after an external and internal analysis of educational needs in elderly patients treated with oral cancer treatments. It implicates a multidisciplinary educational team (nurses, physicians, pharmacists, psychologists, physiologists, social workers...). Six educational workshops were designed with the following endpoints: disease and treatment understanding, treatment management, nutrition and psychological as well as physical well being. ADOPT-PRESTAGE is a clinical, prospective, interventional, open-label, multicenter, randomized, controlled trial designed to evaluate the impact of PRESTAGE program. It is, to the investigators' knowledge, the first randomized controlled trial evaluating the acceptability and impact (adherence, clinical benefit) of an educational program in an elderly cancer population. The primary endpoint of this trial will be to evaluate adherence using an indirect objective adherence measure: the Medication Event Monitoring System (MEMS). Secondary endpoints include quality of life, evaluation of changes in patients' behaviors and economic evaluation.