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Neoplasms, Second Primary clinical trials

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NCT ID: NCT03952312 Completed - Cancer Clinical Trials

Oncotool for Cancer Medications

Start date: January 15, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the efficacy of a psychosocial eHealth intervention on the proposed primary outcomes, TKI adherence and health related quality of life (HRQoL), in patients taking TKIs for cancer management. The intervention components include psychosocial management strategies, cancer medication knowledge and embedded physician reports. The intervention will be delivered via an online application over an 8-week period. Participants in the intervention will complete bi-weekly side effect questionnaires as part of their study involvement, which may trigger an alert to their prescribing physician if they reach a certain threshold. Participants in the control will not complete these questionnaires. Participants are randomized into either an intervention application (described above) or a control application (health information and general health promotion strategies). Aside from having access to the online application for the recommended 8 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), post-intervention (8 weeks after baseline) and a 6-month follow-up.

NCT ID: NCT03936205 Completed - Metastatic Cancer Clinical Trials

Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer

Start date: August 2016
Phase: Phase 2/Phase 3
Study type: Interventional

Pain is a common symptom in patients nearing the end of life. Its prevalence varies between 30 and 75%. Nowadays, morphine is the most used molecule as first line treatment of moderate to severe pain. However, this molecule, considering its side effects, may contribute in part to the discomfort of these patients and may increase the pre-existing agitation or delirium. There is therefore a need to find new agents, other than morphine, for pain control at the end of life, without the limitations that the morphine molecule has. The author reviewed the literature on the role of dexmedetomidine in the treatment of refractory symptoms in palliative care, including pain. It is an agonist of the adrenergic alpha 2 receptor having a sedative, analgesic action and a morphine sparing effect demonstrated postoperatively. This study aims primarily at demonstrating that dexmedetomidine has a beneficial role in the treatment of pain in patients with metastatic cancer.

NCT ID: NCT03895216 Completed - Bone Metastases Clinical Trials

Identification and Characterization of Predictive Factors of Onset of Bone Metastases in Cancer Patients

PreMetOn
Start date: December 3, 2018
Phase:
Study type: Observational

The aim of the present study is to identify deregulated miRNAs in oncological patients with bone metastases present within the circulating exosomes and responsible for the biological mechanisms involved in the process of bone metastasis, in order to obtain a panel of biomarkers predictive of this risk. Through appropriate molecular screening methods a specific panel of significantly deregulated miRNAs will be identified; subsequently bioinformatics analyzes through the use of dedicated databases will be carried out, based on literature data and predicted protein targets in order to identify their potential role in tumor progression, and especially in the onset of bone metastases. Attention, therefore, may be focused on the individual miRNAs identified through individual analysis analyzes of gene expression. These biomarkers could also serve as therapeutic targets, allowing to improve the effectiveness of current therapies and to undertake timely and appropriate therapeutic choices, developed on the basis of the patient's molecular characteristics

NCT ID: NCT03888638 Completed - Colorectal Cancer Clinical Trials

The Role of Tumor-associated Macrophages in Colorectal Liver Metastases

Start date: January 1, 2015
Phase:
Study type: Observational

Colorectal cancer is a major cause of mortality worldwide. Most patients develop colorectal liver metastases (CLM), and for such patients hepatectomy combined with chemotherapy may be curative. Nevertheless, in the era of precision medicine there is a critical need of prognostic markers to cope with the heterogeneity of CLM patients. Tumor-associated macrophages (TAMs) pave the way to tissue invasion and intravasation providing a nurturing microenvironment formetastases. The quantification of immune landscape of tumors has provided novel prognostic indicators of cancer progression, and the quantification of TAMs might explain the heterogeneity of CLM patients. Here, we will investigate the development of a new diagnostic tool based on TAMs with the aim to define the causative role of TAMs in CLM patients. This will open new clinical scenarios both for the diagnosis, therapy and prognosis, leading to the refinement of the therapeutic output in a personalized medicine perspective.

NCT ID: NCT03831243 Completed - Neoplasm Metastasis Clinical Trials

A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases

ROBOMET
Start date: April 9, 2019
Phase: N/A
Study type: Interventional

This is a phase III randomized-controlled, single-blind study comparing the standard schedule for antalgic radiotherapy of a single fraction of 8.0 Gy delivered through three-dimensional conformal radiotherapy (3D-CRT) to a single fraction of 20.0 Gy delivered through stereotactic body radiotherapy (SBRT). The primary aim of this trial is to double the complete response rate. Secondary aims are to compare general response rates, duration of pain response, acute and late toxicity, HRQoL through patient-reported outcome measures (PROMs), pain flare, and re-irradiation need.

NCT ID: NCT03757858 Completed - Cancer Clinical Trials

Hyperthermia Combined With Immunotherapy in the Treatment of Abdominal and Pelvic Malignancies or Metastases

Start date: March 1, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

It is a non-randomized pilot study.The allocation will be determined by patients or their immediate family members who were cooperative with physician's interpretations on the disease progression and updated information of cutting of edge treatment, the financial affordability, availability of treatment plans, possible tolerance or risks etc.The purpose of this study is to investigate the clinical efficacy and toxicity of autologous cellular immunotherapy combined with hyperthermia in abdominal and pelvic malignancies or metastases patients. Furthermore, to characterize response to different regimens,the investigators intent to explore the predictive and prognostic biomarker, as well as the changes in immune repertoire.

NCT ID: NCT03749460 Completed - Clinical trials for Metastatic Malignant Neoplasm in the Bone

Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers

Start date: January 15, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and how well nivolumab and ipilimumab works when given together with stereotactic body radiation therapy (SBRT) in treating patients with salivary gland cancers. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving nivolumab and ipilimumab and SBRT may work better in treating patients with advanced salivary gland cancers.

NCT ID: NCT03733184 Completed - Clinical trials for Colorectal Cancer Metastatic

Development of an IDEAL Framework to Standardise Cytoreductive Surgery for Colorectal Peritoneal Metastases

IDEAL-PM
Start date: March 10, 2016
Phase:
Study type: Observational

Cytoreduction surgery (CRS) followed by hyperthermic intra-operative peritoneal chemotherapy (HIPEC) is a relatively new treatment for selected patients with peritoneal metastases of colorectal origin (PMCR). Data from outside of trials suggest that CRS and HIPEC improves survival compared with the current standard care (chemotherapy). The big challenge is to do trials in this setting - as the intervention is complex, and there are wide variations in the process and recording of outcomes. If trials can confirm the findings from non-randomised studies there are an estimated 1000 to 2000 patients who may benefit from this intervention in the UK each year. The aim of this study is to develop a framework which can be used to undertake a randomised trial in patients with PMCR suitable for CRS with or without HIPEC. The investigators will address this using the principles of the IDEAL (Idea, Development, Evaluation, Assessment & Long term study) framework. Here, a pre-trial feasibility study will be performed between the two national peritoneal tumour treatment centres (Manchester and Basingstoke). This study is designed as such that it will take place over the following four stages: Stage 1. Comparing the treatment data from 100 operations from each of the two centres to identify which of the key components of the intervention differ as well as testing for differences in overall survival and recurrence free survival. Stage 2. Identifying sources of these differences by selecting up to 25 patients and investigating the variation in the way surgeons score key aspects of the procedure Stage 3. Development of a 'trial manual' with standardised definitions (to minimise any differences) Stage 4. Test how well people follow the manual in practice. After this study is complete, it will be possible to use the resulting trial manual to design future randomised trials to test the most suitable clinical question.

NCT ID: NCT03670992 Completed - Clinical trials for Renal Cell Carcinoma

Surgical Treatment of Pancreatic RCC Metastases

Start date: January 10, 2016
Phase:
Study type: Observational

Data from 26 patients undergoing resection of Pancreatic Metastases and extra-Pancreatic Metastases from RCC were retrospectively analysed. Clinical data were collected from a digital database and QoL was assessed through patient's interview and Karnofsky performance scale.

NCT ID: NCT03651271 Completed - Clinical trials for Advanced Prostate Cancer

Nivolumab With or Without Ipilimumab in Advanced Metastatic Cancer

Start date: October 17, 2018
Phase: Phase 2
Study type: Interventional

This is an open-label, exploratory study to evaluate nivolumab with or without ipilimumab based on percentage of tumoral CD8 cells at the time of treatment in participants with varying advanced solid tumors. Participants who have a tumor with ≥ 15% CD8 cells (classified as CD8 high) will receive nivolumab monotherapy, and participants who have a tumor with < 15% CD8 cells (classified as CD8 low) will receive ipilimumab in combination with nivolumab.