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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: 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: 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.

NCT ID: NCT03296137 Not yet recruiting - Cancer Clinical Trials

Adoptive Cell Therapy Across Cancer Diagnoses

Start date: October 14, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study will perform tumor-infiltrating lymphocyte (TIL)-based adoptive T-cell therapy in combination with checkpoint inhibition on cancer patients across all cancer diagnoses.

NCT ID: NCT03279991 Not yet recruiting - Cancer Clinical Trials

Neuromed- Integrated Health Life Platform and Biobank

PLATONE
Start date: June 1, 2018
Phase: N/A
Study type: Observational

This project aims to create a digital platform for personal, clinical, diagnostic and environmental data collection, management and analysis of patients with cardiovascular and neurological disease or cancer admitted to the Neuromed Group clinics, associated with a biobanks of biological fluids and human tissues and a biotechnological platform for "omics" analysis, to encourage personalized, preventative and predictive care.

NCT ID: NCT03272880 Not yet recruiting - Cancer Clinical Trials

Utilizing the Arts to Improve Health, Resilience, and Well-Being Among Cancer Patients and Their Caregivers

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

The purpose of this study is to evaluate the impact of arts-based programming on health, well-being, and resilience. Patients who have cancer or are the caregivers of someone with cancer are being asked to take part in this study.

NCT ID: NCT03262311 Not yet recruiting - Cancer Clinical Trials

Pimo Study: Extracellular Vesicle-based Liquid Biopsy to Detect Hypoxia in Tumours

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to test the potential of a relatively simple serum assay that aims to identify patient subpopulations whose curative radiotherapy outcome is likely to be compromised by radiobiological tumour hypoxia (prognostic value) and who are most likely to gain (predictive value) from the addition of radiation sensitiser drugs or targeted radiotherapy dose escalation.