
Multi-Centre, Retrospective, Open Label Study, to Validate ML-PrediCare by Patients With Melanoma...
MelanomaThis is a retrospective, open label study to establish and validate a prediction technology for advanced melanoma patients under the 1st, 2nd and later treatment lines, with the immunotherapeutic drugs Ipilimumab, Pembrolizumab & Nivolumab, in order to predict response rate and disease progression

ESD for the Treatment of Early Barrett's Neoplasia
Barrett EsophagusEsophageal NeoplasmThis study assesses the quality of the resection of early neoplasia arinsing in Barrett's esophagus using endoscopic submucosal dissection. It is a multicenter prospective registry among 7 centers including all consecutive patients with early Barrett's neoplasia of 15 mm or more in size treated by endoscopic submucosal dissection.

Symbiotics to Prevent Postoperative Infection in Colorectal Cancer
Colorectal CancerSurgical Site InfectionThis is a double blind randomized trial in which patients with colorectal cancer undergoing surgery will be selected to receive either a symbiotic formulation or placebo. The researchers will compare incidence of surgical site infection between the study groups.

Viral Load Changes in Lymphoma Patients With HCV Infection After Chemotherapy
LymphomaHepatitis C Antibodies1 moreIn last few years, most researches about hepatic complication after chemotherapy focused on hepatitis B virus (HBV). With adequate prophylaxis and monitor, HBV-related hepatitis flares can be prevented. In contrast, cancer patients with hepatitis C virus (HCV) infection are traditionally considered as relative safe to receive chemotherapy. However, two large retrospective studies recently showed that severe hepatitis could develop in 14-27% lymphoma patients with chronic HCV infection, including 3-4% hepatic failure. The risk factors to predict severe hepatitis are pre-treatment elevated ALT level and liver cirrhosis. Due to the lack of prospective studies, the dynamic changes of serum HCV RNA levels and the association of hepatitis are still unclear. Some epidemiologic studies demonstrated an association between HCV infection and B-cell lymphoma. Diffuse large B-cell lymphoma (DLBCL) is the most common lymphoma and several reports showed higher prevalence of HCV infection among DLBCL patients than the controls. HCV infected DLBCL patients are reported to have distinct clinical characteristics, such as older, more with elevated LDH levels, and more with extra-nodal involvement. Regarding the impact of HCV infection on prognosis, the results are conflicting. Taiwan is an endemic area of HCV but there are limited reports addressing the clinical characteristics and prognosis in this unique population. Therefore, the investigators initiate a prospective, multi-center observational study to clarify the dynamic association between serum HCV RNA levels and hepatitis in HCV-infected lymphoma patients treated with chemotherapy.

Assessment of Quality of Life After Adjunct Radioiodine Therapy in Patients With Differentiated...
Thyroid NeoplasmsThe aim of this study was to assess the impact of adjuvant radioactive iodine therapy on the quality of life(QOL) in differentiated thyroid cancer patients and to identify independent factors affecting changes in the QOL.

Determinants of Quality Of Life in AGEd Cancer Patients
Colorectal NeoplasmsProstatic NeoplasmsPatients face multiple stresses and challenges in the aftermath of cancer diagnosis. Despite needs perceived by elderly patients might differ from those of younger patients, there is a paucity of published data assessing the specific evolution and relevant determinants of health-related quality of life (HRQoL) in older patients with cancer. Such determinants may include cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features, but also practical organization of care -frequency, geographical distance, supporting measures -, or psychosocial and material support - social network, housing conditions and contextual neighborhood features. Comparatively to dementia or cancer in younger patients, little is known in the oncogeriatric field of the impact on caregivers' perceived burden and HRQol of the support they provide to patients. Further, the potential interactions between patients' and caregivers' HRQoL remain largely unknown, while caregivers are often themselves old with chronic diseases and/or daily living activities' limitations. The DEQOLAGE study is a prospective observational cohort study that aims to describe the HRQoL of patients aged over 70 years with a colorectal or prostatic cancer during the first year following the diagnosis of the disease as well as the HRQoL and burden in their main caregivers. This study will allow a comprehensive assessment of multiple determinants of HRQoL operating at different levels, including individual (cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features), contextual (social network, housing conditions and contextual neighborhood features) and organizational factors (frequency, geographical distance, supporting measures). We also hypothesize that complex interactions may operate between patient's and caregiver's HRQoL and perceived burden. Quality of life measurement will be based on two recent scales specifically designed for the elderly to confirm their psychometric properties and in-field feasibility.

Human EGFR Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)
Non Small Cell Lung CancerEGFR-TKI Resistant Mutation1 moreIn this clinical trial, investigators select FFPE and plasma samples of non-small cell lung cancer which are used for quantitative detection of four kinds of EGFR(Epidermal Growth Factor Receptor) mutations. By the following two aspects, investigators evaluate the clinical performance of the EGFR quantitative kits. methodology validation: To certify the equivalence between the EGFR quantitative kit and the common used detection methods. analysis of the relationship between the type and proportion of EGFR sensitive mutation and EGFR-TKI benefit.

Predictive Biomarkers for IGF1R Targeted Therapy in Ovarian Cancer
Ovarian CancerThe main goal of this study is to employ a novel proteomic approach to identify predictive tumor biomarkers that will increase the efficacy of insulin-like growth factor (IGF1R) targeted therapy in epithelial ovarian cancer. It is expected that these predictive biomarkers will be applied to increase the response rate in selected groups of patients.

Rectal Sparing Approach After Preoperative Radio and/or Chemotherapy in Patients With Rectal Cancer...
Rectal NeoplasmsThe proposed study is an observational, prospective, multicenter study of patients undergoing neoadjuvant therapy for medium-low rectal cancer. Recently the investigators have published the findings of a multicenter Italian phase II study showing that the rate of local recurrence, with a 3 year follow-up, is less than 5% in patients with baseline T2-3 mid-low rectal cancer who, after preoperative chemoradiotherapy (pCRT), showed a major clinical response and underwent a transanal local excision. Based on these results, an organ-sparing approach for patients showing a major clinical response is feasible without reducing the good results obtained with the standard treatment. While a phase III trial is the best way to compare the standard treatment with the organ-sparing approach (local excision or wait-and-see) it is impracticable and likely unethical. An observational study is therefore one of the best way to evaluate the impact that an organ-sparing approach may have on oncological outcomes, quality of life, and bowel function for patients with rectal cancer who, after a pCRT, show a clinical major/complete response. This phase II trial is designed to test the hypothesis that conservative treatments, in patients with low-mid rectal cancer who undergo a major or complete clinical response after neoadjuvant treatment, will be safe and effective compared to standard surgery. The investigators will compare rectum-sparing approaches to standard surgery, firstly in terms of rate of organ preservation at 2 years. Additionally they will compare survival outcomes (DFS, OS), stoma rates, clinical and tumor factors related to pathological complete response, correlation between major and complete clinical response. To add value, the investigators will measure QoL in patients treated with rectum-sparing approaches in comparison to patients treated with standard surgery (TME or abdomino-perineal amputation). Rectum-sparing approach can be considered clinically acceptable if percentage of conservation of the rectum at two years is not less than 50%. The collected data on 164 patients who underwent "rectum-sparing" allow to test the hypothesis that the rectum is preserved in 60% of patients with 80% power (exact binomial test for proportions, alpha = 5 %, 1 tail) and the study will be considered positive if it obtains a frequency of conservation of the rectum of not less than 87 cases. The analysis results will be reported in accordance with STROBE guidelines (von Elm et al., 2008). For all analyzes, continuous variables are described using the mean and standard deviation of position and appropriate measures when appropriate. Categorical variables will be described using the contingency tables.

An Observational Research Of Crizotinib's Hepatic Toxicity In Non-small Cell Lung Cancer Patients...
Non-Small Cell Lung CancerCrizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), was approved by Food and Drug Administration (FDA) for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) and its administration has achieved considerable success. However, adverse effects inevitably occurred and the most common one was hepatic toxicity, appearing as elevating alanine aminotransferase(ALT) and aspartate aminotransferase(AST). Therefore, the investigators try to figure out the mechanism of crizotinib-inducing hepatic toxicity, and explore whether there is any biological marker to diagnose this side effect in an early stage, which may realize individualized therapy with more efficacy and less side effects.