Active clinical trials for "Neoplasms"

Multicenter case cohort study investigating clinical risk factors for clinically relevant bleeding in hemato-oncology patients, as well as bleeding related biomarkers during intensive treatment.

The formation of a colostomy following surgery for rectal cancer changes body image, challenges patient practical skills and threatens quality of life. As the oncological results have improved over the last decades the number of survivors from rectal cancer who have to adjust to a cancer free life in their own homes is increasing. To enable the identification of the patients with stoma-related reduced health-related Quality of life (HRQoL) in a quick and reliable way we recently developed the Colostomy Impact Score (CI-score) comprising 7 items of stoma related factors with significant impact on HRQoL. The purpose of the present project is to perform an international validation of the CI-score and to demonstrate its applicability. The construct validity of the CI-score will be studied internationally on crosssectional cohorts of patients with permanent colostomy after abdominoperineal excision (APE) or Hartmann's procedure in Denmark, Sweden, Spain, the Netherlands, United Kingdom, Turkey, Brazil, Egypt, Russia, Lithuania, Israel, Portugal, South Africa, Australia and China. This will be done by testing the CI-score against five anchor questions stoma impact on HRQoL, the 5 Level version og the EuroQol measuer (EQ-5D-5L) and version 3.0 of the Quality of Life Questionnaire from the European Organisation for Research and Treatment of Cancer (EORTC QLQ C30 questionnaire v3.0). The impact of the challenges related to having a stoma may vary with different demographic, socioeconomic and cultural factors. Supplementary data on stoma care, demographics and socioeconomic status will be gathered to study the impact of patient-related factors and cultural differences on HRQoL in rectal cancer survivors with an ostomy.

This study proposes to investigate the effect of treatment of neuroblastoma on nutritional status, assessed by body mass index (BMI) z score, and body composition evaluated by mid-upper arm circumference (MUAC), from diagnosis through 1-year post end of treatment. The study also aims to investigate the nutritional status and its role in toxicities, infection, survival rates, disease relapse, cost of care and readmission rates, as well as health-related quality of life. The study will take place in Sao Paolo in Brazil, where an estimated sample of 50 children with neuroblastoma will be recruited for the period of 2 years.

No prospective data exist about long term morbidity and quality of life after multivisceral surgical resection for retroperitoneal soft tissue sarcoma (RSTS). In order to assess the safety of this surgical approach and the effect on the Quality of Life over the long period we propose a prospective observational study. The hypothesis is that the surgical treatment has no significant impact in determining a lower Quality of Life in the long term. Objectives Primary objective Estimate the difference between baseline and 4 and 12 months scores of the "global health status / QoL" scale in patients primarily treated for localized RSTS, as determined in QLQ-C30 version 3.0. Secondary objectives Evaluate the long term morbidity of aggressive surgical approach to RSTS in terms of renal failure. Evaluate the difference between baseline and 4 and 12 months scores of DN4 / LEFS / BPI questionnaires. Evaluate the difference between baseline and 4 and 12 months scores of the following scales from QLC-C30: PF2, RF2, EF, CF, SF, FA, FI. Evaluate the difference between baseline and 4 and 12 months scores of the following scales and single items from QLC-C29: Blood and mucus in stool, Stool frequency, Sexual interest, Impotence, Dyspareunia. To correlate the surgical resection pattern (number and type of organs resected) and the tumor features (size, grading and histological subtype) with the long-term morbidity and quality of life. Eligibility Inclusion criteria Adult patients (age > 18 years) with primary localized RSTS surgically treated at our institution Written, voluntary, informed consent Exclusion criteria - Recurrent disease

The main objective of this research is to develop a new scanning technology called the Fast Raman device, to accurately check the skin removed by the surgeon and detect any residual cancer cells; if found, additional skin can then be removed by surgeons on the same day. The device will be tested first for patients undergoing Mohs micrographic surgery, then be extended to wide-local excisions of basal cell carcinoma (BCC). This study will determine the validity (sensitivity/specificity) and reliability (inter- and intra-user variability) of the Fast Raman device for checking the completeness of tumour removal during Mohs micrographic surgery of BCC.

The investigators will evaluate the outcomes of allogeneic stem cell transplantation which is the only curative treatment modality in the patients with chronic myeloid leukemia after failing tyrosine kinase inhibitor therapy. However, any update was not reported on the transplant outcomes in the patients failed TKI therapy, thus necessitating update of this data. Also, the European Group for Blood and Marrow Transplantation (EBMT) risk score is still of value, but insufficient numbers of patients have been transplanted in recent years and after TKI therapy to allow a robust reanalysis. Our study hypothesis is that allogeneic SCT treatment modality can rescue CML patients who failed TKI therapy due to resistance or to intolerance with improved survival and long-term outcomes. Also, another hypothesis will be examined if the EBMT risk score proposed pre-imatinib era can reproduce similar prognostic risk stratification of long-term outcomes in the patients treated with TKI.

The purpose of this study is to investigate the changes of lymphocyte subsets in chemotherapy course of patients with non-small cell lung cancer

Summary of scientific evidence and rationale of this project: Integrative molecular-genetic approaches have provided important insights in the biology of glioblastoma. It has meanwhile become clear, that glioblastoma is not a single tumor entity but comprises different molecular subtypes, which are associated with a distinct genetic/epigenetic signature and prognosis. Multimodal treatment approaches combining radio- and chemotherapy as well as the recent introduction of novel antiangiogenic agents have resulted in increasing survival times and improved quality-of-life of glioblastoma patients. Yet, despite these intense treatment efforts the therapeutic efficacy in glioblastoma patients is limited, leading in virtually all cases to tumor recurrence and death of the patients. As only a limited fraction of glioblastoma patients undergo second neurosurgery at tumor recurrence (< 10%), post-therapeutic samples are rare and no systematic, large-scale studies exist, which address post-therapeutic morphological and molecular alterations in glioblastoma tumor tissue. Yet, these data would help to improve the understanding of mechanisms involved in therapy-resistance and tumor progression, to develop new therapeutic approaches and could pave the way for personalized treatment strategies.

This study is to follow up on the change of immune response by measuring HPV type 16/18 E6 and E7 specific T cell response and lesion condition in subjects who have administered in DNA-based therapeutic vaccine.

Protocol title: Comparison of cost-effectiveness of continuation maintenance therapy with six cycles of pemetrexed versus pemetrexed until disease progression for metastatic non-squamous non-small-cell lung cancer (NSCLC) Study design: An open-labelled, randomized, phase 2 trial Indication: Patients with stage IV non-squamous NSCLC, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and have received first-line or second-line chemotherapy with pemetrexed plus platinum for 4 cycles Treatment: Maintenance pemetrexed 500 mg/m2 every 3 weeks for six cycles versus until disease progression Objectives: Primary endpoint: 1. Progression-free survival in the intention-to-treat population Secondary endpoints: Cost-effectiveness Overall survival Quality-of-life (QoL) Quality-adjusted progression-free survival (QA-PFS) Quality-adjusted life expectancy (QALE) Tumor response rate Adverse events Planned sample size: 36 patients in each arm; total 72 patients Total number of sites: 1 site Duration of patient enrollment: 3 years