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Disease Progression clinical trials

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NCT ID: NCT03469804 Recruiting - Kaposi Sarcoma Clinical Trials

Phase II Multicentric Study of Pembrolizumab in Classic or Endemic Kaposi's Sarcoma

KAPKEY
Start date: July 1, 2018
Phase: Phase 2
Study type: Interventional

Classic and endemic Kaposi's sarcoma (KS) are lymphangio-proliferations associated with human herpes virus 8 (HHV8), which treatment is poorly codified. Chemotherapies give at best 30-60% of transient responses. While interferon responses are frequent, this drug is often poorly tolerated in elderly patients. Therefore new therapies are needed. Classic KS represents an ideal model for evaluating new drugs since patients do not receive concomitant immunosuppressive regimens nor antiviral therapies. Pembrolizumab, an anti-PD1 monoclonal antibody has recently been shown to improve survival in several solid tumors. In KS few data are available on the role of PD1-PD-L1 axis. A significant PD-L1 expression on HHV8-associated pleural effusion lymphomas and on KS samples have been recently reported. Our experience in classical and endemic KS supports the role of this pathway with expression of PD-L1 by subpopulations of T cells but also NK cells in peripheral blood cells from these patients and expression of PD-L1 by tumor cells in KS lesions. In this study we will evaluate the benefit and safety profile of pembrolizumab in classic and endemic KS.

NCT ID: NCT03362658 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Novel MRI Biomarkers for Monitoring Disease Progression in ALS

Start date: October 2016
Phase:
Study type: Observational

Routine MRI is normal in motor neuron diseases such as ALS. However, advanced MRI techniques can provide an objective measure of degeneration (a "biomarker") by examining brain structure, wiring, chemistry, and function. We will develop and evaluate novel MRI techniques that could improve our understanding of ALS and provide a means to diagnose it sooner and monitor its progression. Importantly, we expect these techniques to improve how new drugs are tested, which may lead to the more rapid discovery of a treatment for ALS. Each participant will have 3 MRI scans over a period of 8 months, along with neurological and cognitive evaluations. Study visits will take 2 - 3 hours. MRI is a safe technique that does not involve radiation.

NCT ID: NCT03336554 Recruiting - Clinical trials for Objective Response Rate for Neoadjuvant Chemotherapy, ORR

Epigenetic Biomarker for Osteosarcoma

Start date: September 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

hMe-Seal is a low-input whole-genome cell-free 5hmC sequencing method based on selective chemical labeling. It uses β-glucosyltransferase (βGT) to selectively label 5hmC with a biotin via an azide-modified glucose for pull-down of 5hmC-containing DNA fragments for sequencing. After selectively constructing 5hmC library, highthroughput-sequencing will be performed on an Illumina Nextseq-500 instrument. By ways of Rawdata processing, differential loci between Osteosarcoma group and control group will be detected to indentify specific epigenetic biomarkers of Osteosarcoma.

NCT ID: NCT03332368 Recruiting - Recurrence Clinical Trials

Clinical Study on Triple Negative Breast Cancer With Chinese Medicine

Start date: January 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

Breast cancer is one of the most serious threat to women's health of malignant tumors, also the most common causes of cancer death in women.Triple-negative breast cancer (TNBC) refers to the immunohistochemical detection of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor-2 (Her-2) are negative.Compared with other types of breast cancer, TNBC has a high degree of invasion,local recurrence and metastasis. Also,TNBC can not use endocrine therapy and lack of molecular targeting for Her-2 target therapy.Meanwhile other biological agents are too expensive,so the current clinical therapy only can use in China is chemotherapy,the average survival time is about 2 years. Fortunately,due to the impact of traditional Chinese medicine(TCM) in China, the majority of breast cancer patients have received varying degrees of TCM treatment, and because of TNBC patients can not be more mature endocrine therapy and anti-molecular targeted therapy Benefits, Chinese medicine play an important role in TNBC patients.TCM regulate immune function, inhibit tumor growth, Anti-recurrence and metastasis, to extend the survival of patients with tumor, and relative to chemotherapy drugs and molecular targeted drugs,improve the quality of life.In addition ,comparing with the biological agents,Chinese medicine prices are relatively low,and can be worth using widely. With the development of evidence-based medicine, and gradually recognize the importance of comprehensive treatment of breast cancer, Cancer Treatment Model has been proposed,.That is, to take Chinese medicine, surgery, radiotherapy and chemotherapy, endocrine therapy and biological immunization and other standardized, individualized comprehensive treatment. The introduction of evidence-based medicine into the field of research, will be beneficial to the objective evaluation of TCM syndrome differentiation in the treatment of refractory breast cancer in the characteristics and advantages in order to promote the use of. This study based on TCM syndrome differentiation and treatment, and adopts multi-center, randomized, double-blind and controlled research methods to evaluate whether the intervention of traditional Chinese medicine can improve the TNBC patients with disease-free survival (DFS), overall survival(OS),and the best time to intervene in traditional Chinese medicine; also the establishment of the exact effect, obvious advantages and evidence, can be promoted in line with clinical practice of the program, the formation of refractory breast Cancer and Western medicine combined with clinical path, and relying on the national clinical research base of Chinese medicine information platform, the construction of clinical information management cloud platform, the formation of active medical service process, the establishment of refractory breast cancer combined with clinical prevention and treatment center, improve the life quality level of TNBC patients. The study contains 5 locations,including Longhua Hospital, Shuguang Hospital,Yueyang Hospital,Zhejiang Traditional Chinese Medicine Hospital and Fudan University Cancer Hospital.Considering of the results of the study at MD Anderson Cancer Center in foreign countries showed that the 3-year survival rate of TNBC patients was significantly shorter than that of non-TNBC patients (74% vs.89%, P <0.01) To be at least 10% survival rate.At the same time, considering the case lost rate of 20%, calculated by PASS software, the number of samples for each group of 310 cases, a total of 620 cases of cohort study. According to whether to take traditional Chinese medicine,all the participants are divided into exposure group and non-exposure group, the number of observations per group is 310. Before the research, all participants needs to fill in the informed consent form, investigators introduce the clinical research related matters to them and record the basic situation. The Chinese medicine exposure group take Chinese medicine(San Yin Decoction ) besides of original Western medicine , non-exposed group only received Western medicine treatment, a total of two years.All results are recorded in the CRF table,and use SPSS18.0, Stata10.0 and other statistical software for data to analysis.

NCT ID: NCT03278899 Recruiting - Clinical trials for X-Linked Adrenoleukodystrophy

A Study to Prospectively Assess Disease Progression in Male Children With X-ALD

Start date: February 16, 2018
Phase:
Study type: Observational

This is a non-interventional, multi-center study that follows general principles of periodic assessment of X-ALD patients in routine practice. No study drug treatment will be given and no changes to patient treatment are necessary.

NCT ID: NCT03150602 Recruiting - Clinical trials for Peripheral T Cell Lymphoma

A Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy

Start date: August 30, 2016
Phase: Phase 4
Study type: Interventional

This study is to evaluate the objective response rate to pralatrexate in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)

NCT ID: NCT03121768 Recruiting - Bladder Cancer Clinical Trials

A New Prognostic Model for Predicting the Outcome of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Start date: May 15, 2017
Phase: N/A
Study type: Observational

A prospective observational study to re-establish a new prognostic model for predicting the outcome in patients with non-muscle invasive bladder cancer (NMIBC) using the current recommendation regimen for intermediate and high risk groups and including all potential and highly prognostic factors.

NCT ID: NCT03100955 Recruiting - Clinical trials for Progression Free Survival

A Study of Standard Treatment +/- Apatinib in Extensive Stage Small Cell Lung Cancer

Start date: March 1, 2017
Phase: Phase 3
Study type: Interventional

To establish the progression free survival in patients with extensive stage small cell lung cancer treated with cisplatin and etoposide plus or not apatinib

NCT ID: NCT03020394 Recruiting - COPD Exacerbation Clinical Trials

Respiratory Support in Severe Chronic Obstructive Pulmonary Disease Exacerbation

Start date: January 2017
Phase:
Study type: Observational

Preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients who have severe exacerbation of COPD. Recently, large-scale comparative effectiveness research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality rates. But there's no high-quality clinical studies which can confirm this. Therefore, investigators believe that NPPV can avoid intubation in patients with severe exacerbation of COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, in order to reduce IMV-related complications and improve patients' outcomes.

NCT ID: NCT03014869 Recruiting - COPD Exacerbation Clinical Trials

High Flow Nasal Cannula vs NPPV in Moderate Chronic Obstructive Pulmonary Disease Exacerbation

Start date: January 2017
Phase: N/A
Study type: Interventional

For moderate AECOPD(pH<7.35), several guidelines have strongly recommended NPPV as standard therapy, which can reduce the rate of intubation and mortality. A few previous studies have shown that HFNC can efficiently improve alveoli ventilation and breathing pattern in some severe AECOPD patients. Therefore, we hypothesize that HFNC is not inferior to NPPV for preventing endotracheal intubation in moderate AECOPD patients. To assess this hypothesis, we performed a multicenter, randomized, noninferiority trial of HFNV vs NPPV in moderate AECOPD patients.