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NCT ID: NCT01516567 Active, not recruiting - Clinical trials for Primary Mediastinal Large B Cell Lymphoma

Intergroup Trial for Children or Adolescents With Primary Mediastinal Large B-Cell Lymphoma: DA-EPOCH-Rituximab Evaluation

Start date: April 1, 2012
Phase: Phase 2
Study type: Interventional

Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.

NCT ID: NCT01513408 Active, not recruiting - Breast Cancer Clinical Trials

Relevance of T Lymphocytes Tumor Infiltrates CD8 and Foxp3 as Immune Prognostic Biomarker in Breast Cancer Treated by Neo Adjuvant Chemotherapy

PRIMUNEO
Start date: May 2012
Phase: N/A
Study type: Interventional

Neoadjuvant chemotherapy is standard therapy for the management of localised breast cancer, and makes it possible to evaluate tumour response. Achieving pathological complete response (pCR) after chemotherapy is the most important prognostic factor for these patients. However, patients with pCR can suffer relapse. In parallel, long-term prognosis of patients who do not achieve pCR is poorly documented, and no specific prognostic factors have been clearly identified.Preclinical and clinical studies argue for an immunogenic role of some chemotherapy regimens, such as anthracyclines, taxanes or trastuzumab. By facilitating recruitment of CD8 T-lymphocytes in the tumour bed, these agents could favourably influence antitumour immune response, partially contributing to efficacy. Conversely, tumours can promote accumulation of regulatory T-lymphocytes expressing Foxp3, thus evading anti-tumour immune response, and increased numbers of regulatory T-cells are associated with less favourable prognosis in breast cancer patients. We have previously shown that a high number of CD8 T-cells associated with low Foxp3 infiltration, as quantified by immunohistochemistry on surgical specimens, is associated with better response and better survival in breast cancer patients, independently of whether pCR was achieved, the type of chemotherapy used, and the type of breast cancer. Therefore, we propose to validate in a prospective study this immunological prognostic marker in a large cohort of patients treated with neoadjuvant chemotherapy.

NCT ID: NCT01504815 Active, not recruiting - Clinical trials for Head and Neck Cancer

Adaptive Radiation Treatment for Head and Neck Cancer

ARTFORCE
Start date: March 2012
Phase: Phase 3
Study type: Interventional

This Phase III trial aims to: Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN. The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area. To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.

NCT ID: NCT01502696 Active, not recruiting - Ulcerated Melanomas Clinical Trials

Adjuvant PEG Intron in Ulcerated Melanoma

Start date: October 2012
Phase: Phase 3
Study type: Interventional

Patients with an ulcerated melanoma with Breslow >1 mm, N0M0 have a significantly higher risk for relapse than patients with a non-ulcerated primary and about a 40-50% chance of developing stage IV disease to which they will almost invariably succumb. In stage I and II patients with an ulcerated primary who have been sentinel node (SN-staged) and found to be SN-negative there is still a 25-30% relapse risk. The purpose of this study is to evaluate the effectiveness and safety when treated with PEG IFN alfa-2b for 2 years as compared to observation (no treatment), administered after adequate surgery has been performed for ulcerated primary cutaneous melanomas.

NCT ID: NCT01495676 Active, not recruiting - Clinical trials for Infiltrating Bladder Urothelial Carcinoma

A Phase II Trial Evaluating an Organ-conserving Strategy by Radiochemotherapy for Muscle-infiltrative Bladder Cancer

GETUGV04
Start date: July 6, 2011
Phase: N/A
Study type: Interventional

If radical cystectomy remains the standard of care for muscle invasive bladder cancer, consequences of this surgical procedure are often harsh. Over the past years, concurrent chemo-radiotherapy has imposed itself as an alternative treatment. Published data on concomitant radiochemotherapy (radiotherapy/cisplatin or radiotherapy/cisplatin/5-fluorouracil combinations) showed local control rates with bladder preservation at 5 years ranging from 40% to 65% according to the disease stage, and overall survival probabilities ranging from 40% to 50% at 5 years. In order to improve local and systemic prognosis, evaluation of other chemotherapy agents with higher radiosensitizing effect, such as gemcitabine, is justified. Gemcitabine possesses its own anti-cancer activities on urothelial diseases and has a synergetic activity with cisplatin. The investigators completed a monocenter phase I study combining radiotherapy, cisplatin, and twice-weekly gemcitabine, and determined a recommended dose of gemcitabine 25 mg/m². The objective of the present study is to evaluate the combination of radiotherapy + cisplatin + gemcitabine in terms of disease-free survival in non metastatic muscle invasive urothelial cancer patients.

NCT ID: NCT01493063 Active, not recruiting - Clinical trials for Prematurity of Fetus

LACTACOL 01 - Impact of Breast Milk on the Neurodevelopment of Preterm Newborns

Start date: October 25, 2011
Phase:
Study type: Observational

The aim of the study is to estimate the impact of the protein content of breastmilk at the end of hospitalization of the preterm newborn, on the neurodevelopment at 2 years old. The investigators expect a difference of at least 5 points of Development Quotient (DQ) when comparing extreme terciles of the protein content of breastmilk at the end of hospitalization.

NCT ID: NCT01492127 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Evaluation of Proteasome as a Marker of Hepatocellular Carcinoma in Cirrhotic Patients Following Curative Treatment

Start date: December 2011
Phase: N/A
Study type: Interventional

This study will evaluate the usefulness of plasma proteasome levels as a tumor marker of hepatocellular carcinoma (HCC) by studying their variation following curative treatment of HCC. The hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence.

NCT ID: NCT01486524 Active, not recruiting - Septic Shock Clinical Trials

Pharmacogenomic Biomarker Study for Recombinant Human Activated Protein C Treatment in Severe Sepsis

Start date: October 2011
Phase: N/A
Study type: Observational

The overall purpose of the study is to determine whether either of the Improved Response Polymorphisms (IRPs) individually predicts a differential DrotAA treatment effect in patients with severe sepsis and high risk of death. This will be an international, multicenter, "prospective-retrospective", nonrandomized, controlled, outcome-blinded, genotype-blinded, matched-patients study. No prospective enrollment or treatment of patients will occur under this protocol. Retrospectively collected clinical data and DNA samples will be analyzed for existing cohorts of patients with severe sepsis who were previously treated with DrotAA (treatment group) or not (control group) as part of their standard care in an ICU.

NCT ID: NCT01486173 Active, not recruiting - Clinical trials for Infant, Premature, Diseases

Early Nutrition and Neurological Development of Very Preterm Infants

EPINUTRI
Start date: June 2011
Phase: N/A
Study type: Observational

The main goal of this study is to determine the association between: - the quantity of mother's milk and duration of breastfeeding - the intake of polyunsaturated fatty acids and iron during hospitalization and the development of preterm infants born with a GA < 32 weeks.

NCT ID: NCT01483456 Active, not recruiting - Clinical trials for Falls Among Elderly Inpatients

Impact of Multidisciplinary Program on Falls in Elderly Inpatients

IPR
Start date: July 2011
Phase: N/A
Study type: Interventional

Falls among elderly inpatients are common, multifactorial and associated with a significant increase of complications and morbidity. According to a recent Cochrane review, the effectiveness of fall prevention program has been assessed in community-dwelling and in long stay wards but not in rehabilitation wards (RW) and geriatric acute wards (GAW). IPR study aims to measure the impact of a multidisciplinary prevention program on falls in elderly inpatients.