Active clinical trials for "Lung Neoplasms"

A small proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN). This is an important group of patients because if it is lung cancer, presentation as a SPN represents early disease, which following surgery has a high 5 year survival rate. However as not all SPNs are lung cancer it would be unethical to biopsy every case. Clinical guidelines recommend that SPNs should undergo an initial (FDG)-PET/CT scan, which may give more information about the SPN and may indicate if it is likely to be lung cancer. However in many cases it does not and current practice is to monitor the SPN with a series of CT scans over 2 years to look for changes or growth which may/ but not always indicate lung cancer. If no changes are observed over 2 years the SPN is considered not lung cancer. This is both expensive for the National Health Service (NHS) and worrying for the patient in terms of monitoring CT costs and delayed treatment due to length of time to diagnosis. This study examines the diagnostic capacity of using a different CT scan. Dynamic Contrast Enhanced -CT(DCE-CT). DCE-CT and FDG-PET/CT scans give different information about the SPN and the investigators will look to see if information from either scan or combined information from both scans may be better in the diagnosis of early stage lung cancer. The investigators will also undertake a review of previous studies that have used these scans and use data from both the review and the trial to look at the cost effectiveness of using DCE-CT in the diagnosis of SPN. The trial will recruit 375 people who have a SPN detected by a normal CT scan which requires a FDG-PET/CT scan. In addition they will receive a DCE-CT scan either on the same day or within three weeks of the FDG-PET/CT scan. This is the only extra procedure that will take place to normal NHS care, however we will collect clinical and outcome data over the next two years. The study is coordinated by Southampton University clinical trials unit. Recruitment between January 2013 - April 2016, from up to 14 UK sites. Data analysis and conclusions are expected by the end of 2018. The study is funded by the NIHR-HTA

This is a phase IV multicenter trial to evaluate the mechanisms of resistance and pharmacoeconomic (PE) impact of crizotinib and its companion diagnostic test used in a real-life setting in advanced ALK-positive non-small cell lung cancer (NSCLC) patients. The study will address two anticipated issues surrounding personalized medicine and treatment with crizotinib: it will enable real-life Heath Economics and Outcome Research (HEOR) it will validate and/or identify new blood-based or tissue-based biomarkers of resistance to crizotinib. At least 30 patients will be recruited in Quebec and Ontario for the PE study. Patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib. Approximately 25 patients will be recruited to the biomarker sub-study in Quebec to understand resistance mechanisms of crizotinib. In these patients, a biopsy from any accessible metastatic lesion will be obtained when the patient is no longer responding to treatment, as well as blood sampling during regular treatment visits.

The purpose of our study is to investigate the association between respiratory muscle performance, functional capacity, dyspnea, anxiety/depression symptom, 1-year respiratory morbidity rate, and 1-year mortality in patients with primary stage IIIb and IV lung cancer.

Erlotinib is an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase. Higher response rates were observed in a subset of patients with female gender, Asian ethnicity, no smoking history, mutations in EGFR tyrosine kinase, high EGFR gene copy number and adenocarcinoma histology. However, the therapeutic effect of Erlotinib is not confined to patients whose tumors harbor EGFR mutations and other predictors of efficacy of this agent. And these tests require time and sufficiently large specimens for processing, whereas many patients with advanced NSCLC are diagnosed based on cytology alone. This study was designed to evaluate FLT-PET or FDG-PET usefulness in the early assessment of treatment response and in predicting patient outcome after erlotinib monotherapy for patients with non-small cell lung cancer prospectively. Changes in tumor FLT or FDG uptake 7 days after the initiation of treatment will be compared between responders and nonresponders based on subsequent CT scans.

The aim of this study is to evaluate if Electromagnetic navigation (ENB) in combination with rapid on site evaluation (ROSE) can improve diagnostic accuracy in those patients who fail to be diagnosed with conventional fluoroscopic assisted bronchoscopy (FBS) in combination with ROSE.

To establish a retrospective compilation of clinical, histopathological, treatment and follow-up (clinic pathological) data of previous non-small cell lung cancer (NSCLC) cases. To establish a prospective collection of clinic pathological information from NSCLC patients with corresponding blood and tissue samples To discover and validate molecular biomarkers of survival and treatment outcome in NSCLC One of the current difficulties in the management of lung cancer is the decision to treat and the type of treatment to select. Thus there is a need for additional prognostic (indicative of disease aggressiveness) and predictive (indicative of likely response to treatment) markers for lung cancer. To conduct a successful prognostic and predictive marker program, several factors are required, including: a comprehensive database linking clinical, histopathological, treatment and outcome characteristics of each case, a collection of samples linked to the database that is suitable for the testing of candidate markers, and a multi-disciplinary, interdepartmental level of expertise in the management of lung cancer. Objective 1: A review of the case records will be conducted to extract clinical, treatment and follow-up data Objective 2: Patients aged 21 years or more with newly diagnosed, untreated non-small cell lung cancer shall be approached for consent. Patients will be identified through the pathology records, and from the study investigators' clinic. After subject consent, baseline characteristics will be obtained. Follow up data on therapies received and toxicities encountered will be obtained. Tumor samples will be obtained only from patients with NSCLC undergoing surgery as part of routine clinical care. The surgical specimen will be sent to Pathology to verify the adequacy of the diagnostic sample as per usual practice. Blood will be collected at the baseline (or prior to any anti-cancer treatment) and will be sampled again at the time of relapse or disease progression. Collection will entail drawing 7ml blood into a Vacutainer CPT tube (Becton Dickinson, USA), centrifugation, extraction of a separated layer of mononuclear cells (MNC), labeling followed by storage below -80oC. The frequency of blood drawn will be about 1-5 times (7-35mls total). The number of times depends on whether the lung cancer relapses and in the advanced stage, how often the lung cancer relapses after treatment. DNA and RNA will be extracted by CSIS and stored in freezer space there. Stored samples will be used for investigation of prognostic and predictive markers of outcome and for discovery of novel molecular alterations Objective 3: Biomarker analysis of tumor and blood. Blood will be enriched for circulating tumor cells (CTC) using previously optimized methods (11) and DNA will be extracted from CTC and tumor using the Tri-Reagent (Molecular Research Center, Cincinatti, OH). DNA will be extracted from tumor, CTC and mononucleated cells and tested for somatic lung mutations by sequencing (2). Germline DNA will be analysed for genes linked to genetic risk for NSCLC and, for treatment toxicities, for genes related to NSCLC chemotherapy metabolic pathways. Tissue microarray (TMA) is a high-throughput method of analysing large numbers of formalin-fixed, paraffin-embedded tumor at a minimal cost and effort. To analyse the expression of proteins of putative relevance to EGFR function, cell proliferation, angiogenesis, apoptosis, metastasis, and hormonal, TMA will be utilised. PTEN and C/EBPa will also be analysed.

Non-small cell lung cancer (NSCLC) has a poor prognosis if not caught early enough. One of the factors that may impact the ability to control NSCLC is low oxygen levels (hypoxia) inside the tumour. This study will use 18F-FAZA PET scans to assess whether patients have hypoxic tumours and to monitor the changes to the hypoxic areas of a tumour during currently available standard treatment. It is hypothesized that 18F-FAZA PET may predict response to treatment, local control, and/or survival in NSCLC.

Promising new technology exists to examine small proteins that are shed by cancers into the blood stream. The purpose of this study is to see if there are differences in the proteins and protein levels in blood from individuals with early stage lung cancer compared to healthy adults.

Studies indicate that the majority of early-stage non-small cell lung cancer (NSCLC) patients find it important to be involved in treatment decision making. However, in a recent study it has been reported that about 40% of the participants experienced decision conflict and feel uninformed(1). The investigators therefore developed a patient decision aid (PDA) for stage I-II NSCLC patients, that informs and empowers patients to help decide between stereotactic radiotherapy (SBRT) and surgery.

Local percutaneous thermal ablation is frequently proposed in the management of metastatic diseases. Radiofrequency ablation (RFA) has demonstrated good results when the metastatic disease is limited and slowly evolving. The destruction of solid metastasis by RF leads to inflammatory and immunological mechanisms that remain poorly understood. These pathological events may influence the overall and anti-tumor host immune responses. The purpose of the study is to identify and quantify some immune mechanisms triggered by RFA of pulmonary metastases from colorectal cancer origin.