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NCT ID: NCT01479257 Active, not recruiting - Cancer Clinical Trials

Determinants of Multiple Health Risk Behaviors Among Latinos

Start date: January 2012
Phase:
Study type: Observational

The goal of this research study is to learn how cultural, environmental, and interpersonal experiences, as well as personal thoughts and feelings, influence cancer risk behaviors among Latino residents of Houston, Texas.

NCT ID: NCT01477255 Completed - Cancer Clinical Trials

The Feasibility Of a Daily Diary Methodology With a Pediatric Cancer Population

DIARY1
Start date: December 2011
Phase: N/A
Study type: Observational

This investigation seeks to determine the feasibility of an electronic diary methodology among pediatric cancer patients and healthy matched controls. Levels of study participation and compliance will be assessed to assist with determining overall feasibility. Results will offer insight into the effectiveness of this means of data collection with a pediatric oncology population, and will examine how psychosocial and contextual factors contribute to the resiliency that has been demonstrated by children with cancer. Findings will provide data for the design and implementation of a future, larger-scale study with this pediatric population that implements an electronic daily diary methodology.

NCT ID: NCT01476891 Active, not recruiting - Cancer Clinical Trials

The eCALM Study - An Online Mindfulness-Based Stress Reduction Program for Individuals Living With Cancer in Alberta

eCALM
Start date: January 2011
Phase: N/A
Study type: Interventional

For people with cancer, in-person Mindfulness-Based Stress Reduction (MBSR) participation can decrease stress symptoms, mood disturbance, and fatigue, as well as enhance personal growth and spirituality, and improve quality of life and sleep. Online MBSR may improve the accessibility of MBSR programs to underserved cancer patients who are unable to attend available in-person groups. This study will examine whether patients are willing to participate and complete the program, and also whether the online program improves mood and stress.

NCT ID: NCT01476137 Completed - Cancer Clinical Trials

A Study of the Safety and Activity of the MEK Inhibitor Given Together With the AKT Inhibitor to Patients With Multiple Myeloma or Solid Tumor Cancers

Start date: October 26, 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether the MEK inhibitor and the AKT inhibitor can be given in combination and if the combination is effective treatment for patients with solid tumors, including breast cancer and endometrial cancer, and for patients with multiple myeloma.

NCT ID: NCT01476085 Terminated - Cancer Clinical Trials

Evaluating the Utility of the Apoptosis Imaging Biomarker 18F]ML10 in Patients With Non-Hodgkin's Lymphoma(NHL)

Start date: July 2011
Phase: Phase 1
Study type: Interventional

This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in patients with Non Hodgkin's Lymphoma.

NCT ID: NCT01471210 Completed - Clinical trials for Cancer - Solid Tumors and B-Cell Non-Hodgkin's Lymphoma

Safety, Tolerability, Pharmacokinetics, and Immunoregulatory Study of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Solid Tumors and Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Start date: February 2012
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the safety, tolerability, pharmacokinetics and immunoregulatory activity of urelumab (BMS-663513) in cancer subjects with advanced and/or metastatic tumors and relapsed/refractory B-Cell Non-Hodgkin's Lymphoma

NCT ID: NCT01463813 Completed - Cancer Clinical Trials

Finnish Vitamin D Trial (FIND)

FIND
Start date: September 2012
Phase: N/A
Study type: Interventional

The Finnish Vitamin D Trial (FIND) is a randomized, double-blind, placebo-controlled, 5-year supplementation study of the benefits and risks of vitamin D in the primary prevention of cardiovascular (CVD) and cancer among 18000 men 60 years or older and women 65 years or older. [Edit 25.3.2015: Due to difficulties in recruitment and funding, the study size is approximately 2500 subjects, with a 550 subject subgroup with more detailed examinations] The participants will be randomized to 3 groups with 6000 in each, with daily supplementation of either: 1) 40 µg/day (1600 IU) of vitamin D3, 2) 80 µg/day (3200 IU) of vitamin D3, or 3) placebo. [Edit 15.3.2015: The 2500 subjects are randomized in 3 groups, approximately 830 subjects per group.] Compliance, use of non-study drugs or supplements, diet, development of endpoints, and CVD and cancer risk factors will be assessed by questionnaires. Blood samples will be collected for assessment of effect modification by baseline 25-hydroxyvitamin D, as well as for future ancillary studies of genetic/biochemical hypotheses. Event data will be obtained by record linkage from the national computerized hospitalization registry.

NCT ID: NCT01462604 Completed - Cancer Clinical Trials

Pilot Study of Patient's Adherence to TYKERB™/TYVERB™ + Capecitabine in Metastatic Breast Cancer

Start date: November 23, 2011
Phase:
Study type: Observational

This is a 6-week, single arm, pilot study to test the study procedure, educational materials, and measurement instruments for the educational intervention in HER2 overexpressing metastatic or advanced breast cancer patients

NCT ID: NCT01462552 Completed - Cancer Clinical Trials

Physician Liver Function Test (LFT) Monitoring for Tykerb Pts

Start date: December 2010
Phase: N/A
Study type: Observational

In July 2008, the lapatinib (Tykerb) Prescribing Information (label) was updated to include a boxed warning related to hepatotoxcity and detailed instructions for monitoring liver function before and during lapatanib exposure. For patient safety, it is of interest to know the extent to which providers are adherent with these guidelines for hepatic monitoring of lapatanib users. Thus, the aim of this study is to determine if physicians conduct liver function testing prior to prescribing lapatanib and at regular intervals during exposure, and if they withdraw lapatanib, and do not re-treat, for patients who demonstrate severe liver enzyme elevations while exposed. These aims will be tested in the "Pre-label" (prior to the boxed warning) and "Post-label" (after the boxed warning) periods to determine if physician adherence to the guidelines changed as a result of the warning. Specifically, the boxed warning provided the following guidance: "Hepatotoxicity (alanine transaminase or aspartate transaminase >3 times the upper limit of normal and total bilirubin >1.5 times the upper limit of normal) has been observed in clinical trials (<1% of patients) and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain. The hepatotoxicity may occur days to several months after initiation of treatment. Liver function tests (transaminases, bilirubin, and alkaline phosphatase) should be monitored before initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated. If changes in liver function are severe, therapy with lapatanib should be discontinued and patients should not be re-treated with lapatanib" The following objectives will be assessed and compared among patients prescribed lapatanib before and after the addition of detailed guidance on liver function testing to the product label on July 9, 2008: 1. Objective 1: Determine if physicians perform liver funtion tests (LFTs) prior to prescribing lapatanib (baseline) 2. Objective 2: Describe the prevalence of LFT elevations at baseline 3. Objective 3: Determine if physicians routinely perform LFTs during the duration of lapatanib exposure 4. Objective 4: Describe the cumulative incidence and incidence rate of LFT elevations during lapatanib exposure 5. Objective 5: Describe patients that experience severe LFT elevations during lapatanib exposure and calculate the proportion that have lapatanib discontinued and are not re-treated To achieve these objectives, an observational retrospective cohort study will be conducted using the United States Oncology Electronic Medical Records database. The study population will consist of females with a diagnosis of metastatic breast cancer and a documented order for Lapatanib from January 1, 2007 - December 31, 2009. Patients will be categorized by whether they initiated Lapatanib before or after the July 9, 2008 label change. 'Pre Label': Initiated lapatanib between January 1, 2007 and December 31, 2007. Follow-up time for this group will continue until June 30, 2008 to allow these patients to have at least six months of follow-up time prior to the label change. 'Post Label': Initiated lapatanib between July 9, 2008 and December 31, 2009. Follow-up time for this group will continue until June 30, 2010 to allow these patients to have at least six month of follow-up. The exposure in this study is lapatanib oral medication. The date of initiation of lapatanib will be the index date. Lapatanib exposure period(s) will be defined from the index date through to the end of the study period (June 30, 2008 for pre-label group or June 30, 2010 for post-label group). The project will use proportions and two estimates of incidence (cumulative incidence and incidence rates using person-time) to describe the outcomes of interest among the users of Lapatanib before and after the label change. The following LFTs will be considered: - alanine transaminase (ALT) - aspartate transaminase (AST) - alkaline phosphatise (ALP)

NCT ID: NCT01459653 Completed - Breast Cancer Clinical Trials

Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor

Monitor-GCSF
Start date: March 2010
Phase: N/A
Study type: Observational

This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically in physician's best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.