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Neuroblastoma clinical trials

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NCT ID: NCT01986595 Recruiting - Neuroblastoma Clinical Trials

A Pilot Study on ALK Gene Mutations in Neuroblastoma

Start date: August 2013
Phase: N/A
Study type: Observational [Patient Registry]

Neuroblastoma (NB) originates from the sympathetic nervous system and is one of the most common cancers in infants and children. In our hospital, nearly 70% of patients are diagnosed with stage 4, metastatic disease with a poor prognosis, despite the use of multimodal therapy including chemotherapy, surgery, autologous stem cell transplantation, radiation therapy, and differentiation therapy. To improve the survival rate and patient care, our NB Study Group has devoted to the research on NB-specific molecular imaging, biomarkers, and target therapy. We have confirmed studies in cancer genetics by showing that N-myc gene (MYCN) amplification and segmental abnormalities on overall genomic profiling both have an adverse effect on treatment outcome. Therefore, there is an unmet need for the development of novel molecular target therapy in NB. Recently, the anaplastic lymphoma kinase (ALK) oncogene has been found to play an important role in the pathogenesis of NB, as well as serving as the driver mutations in approximately 10% of high-risk NB. The availability of ALK inhibitors also enables ALK as a treatment target in NB. In this proposal, we plan to utilize gene sequencing, array-comparative hybridization, and multiplex ligation-dependent probe amplification methods to evaluate the frequencies and characteristics of ALK mutations and amplifications in patients with NB. The gene and protein expression of ALK will also be evaluated by quantitative polymerase chain reaction(PCR) and immunohistochemistry, respectively, and compared with ALK genotype. The overall genomic pattern, clinical characteristics, histopathology, and treatment outcome of ALK-mutated NB patients will be analyzed. The results from this study may serve as the first report on ALK mutations of NB in Taiwan and will be used for the development of standardized genetic diagnosis protocols, as well as the design of future clinical trials targeting ALK.

NCT ID: NCT01704716 Recruiting - Neuroblastoma Clinical Trials

High Risk Neuroblastoma Study 1.8 of SIOP-Europe (SIOPEN)

Start date: February 2002
Phase: Phase 3
Study type: Interventional

This is a randomized study of the European SIOP Neuroblastoma Group (SIOPEN) in high-risk neuroblastoma (stages 2, 3, 4 and 4s MYCN-amplified neuroblastoma, stage 4 MYCN non amplified > 12 months at diagnosis). The protocol consists of a rapid, dose intensive induction chemotherapy, peripheral blood stem cell harvest, attempted complete excision of the primary tumour, myeloablative therapy followed by peripheral blood stem cell rescue, radiotherapy to the site of the primary tumour and immunotherapy (R4 randomization - isotretinoin and ch14.18/CHO (Dinutuximab beta, Qarziba ®).), with or without s.c. aldesleukin (IL-2)). Patients diagnosed after the closure of R3 randomization will not be R4 randomized. For these patients the use of ch14.18/CHO antibody is recommended without scIL-2 as continuous infusion as standard of care outside of controlled trials. ch14.18/CHO received marketing authorization by EMA in May 2017 (Qarziba ®). In the induction phase, all patients receive Rapid COJEC following the result of the R3 randomization which was closed on June 8th, 2017 after inclusion of 630 patients as planned. Following induction treatment peripheral blood stem cell harvest (PBSCH) is performed and complete excision of the primary tumour will be attempted. Patients with an inadequate metastatic response to allow BuMel MAT followed by PBSCR at the end of induction should receive 2 TVD (Topotecan, Vincristine, Doxorubicin) cycles. After Rapid COJEC induction, localized patients will proceed to consolidation. Patients aged 12-18 months at diagnosis, with stage 4 neuroblastoma, no MYCN amplification and without segmental chromosomal alterations (SCAs) are thought to have a good prognosis and will stop treatment after induction therapy and surgery to the primary tumour. Consolidation consists of BuMel MAT based on the results of the R1 randomization followed by peripheral blood stem cell rescue (PBSCR) and radiotherapy to the site of the primary tumour. The R2 immunotherapy randomization using ch14.18/CHO as 8 hour infusion on 5 consecutive days ( total dose (100mg/m²) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) is closed. The amended R4 immunotherapy randomization using ch14.18/CHO as continuous infusion (total dose 100mg/m² over 10 days) with or without aldesleukin (IL-2) alternated with isotretinoin (13-cis-RA) has accrued according to plan with results pending awaiting data maturity and DMC approval.

NCT ID: NCT01587300 Recruiting - Neuroblastoma Clinical Trials

Neuroblastoma Biology Study

Start date: July 2011
Phase:
Study type: Observational

Medical scientists want to find better ways to treat neuroblastoma and to find ways to prevent the tumor from growing back. To do this, they need more information about the characteristics of neuroblastoma cells. Therefore, they want to study samples of neuroblastoma tissues and neuroblastoma and normal cells in the blood and bone marrow that may be related to the growth of neuroblastoma cells. Doctors and other medical scientists also want to find better ways to detect and measure neuroblastoma to improve the ability to follow the response of tumor cells to therapy.

NCT ID: NCT01525251 Recruiting - Neuroblastoma Clinical Trials

Nurse Case Manager Model on Neuroblastoma Caregiver's Uncertainty

NCMM
Start date: August 2009
Phase: N/A
Study type: Observational

Clinical Problem and Significance: The incidence of neuroblastoma is about 30 cases a year in Taiwan. The five-year survival rate of neuroblastom is near 50% in Taiwan. Compared to the survival rate in Western countries, the treatment in Taiwan needs more efforts to improve. According to the report from the Childhood Cancer Foundation ROC, several children with neuroblastoma did not complete their treatment and or not received the protocol. In addition to the efforts in improving protocol, the reasons for those who drop-out and do not receive complete treatment need the investigators more attention to think of. Purpose of Study: The main purpose is to evaluate the effects of nurse case manager model on caregivers' adaptation of disease uncertainty about then child with neuroblastorna. Methods: A longitudinal and prospective design will be used to perform this study. Questionnaire survey and chart review will be the means of data collection for the part of quantative analysis. The qualitative method , semi-structural interview , also will be used to collect data regarding caregiver's perception of social support and adaptation at the same time of self-report of questionnaires survey .There are five points of time to collect data: Baseline (A), 3 months(B) , 6 months(C), 9 months(D),1 year(E) and 1.5 year(F) after eligible subjects agree to participate in the study. Subjects: The study will use a convenience sample. Once the caregiver's child is on has been diagnosed with neuroblastoma will be recruited in this study. Instruments: Three Chinese versions of Mishel Uncertainty in Illness-Parent Form , the self-reported socio-demographic questionnaire will be used to collect data. Process recording will be typed once finishing interview for further analysis. Data Analysis: Quantitative data will be analyzed using SPSS 15.0 statistical software. The data will be analyzed using descriptive statistics and inferred statistics. Content analysis and theme formation will be categorized to assist the interpretation of quantitative results. Implication: The findings of this study will be expected of the effects of nurse care manager model on children with newoblastoma cancer survivors.

NCT ID: NCT01308905 Recruiting - Neuroblastoma Clinical Trials

Monitor Response to Treatment in Neuroblastoma Using 3&Apos;-Deoxy-3&Apos;-Fluorothymidine- Positron Emission Tomography (FLT-PET)

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

The purpose of this study is to gain knowledge about how to best diagnose and treat tumors, how tumors affect normal tissue and how treatment of tumors with radiation therapy and chemotherapy affect tumors.

NCT ID: NCT01109394 Recruiting - Sarcoma Clinical Trials

Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies

Start date: April 21, 2010
Phase:
Study type: Observational

Background: - Laboratory investigators who are studying common childhood cancers are interested in developing a tissue repository to collect and store blood, serum, tissue, urine, or tumors of children who have cancer or adults who have common childhood cancers. To develop this repository, additional samples will be collected from children and adults who have been diagnosed with common childhood cancers such as leukemia and tumors of the central nervous system. Objectives: - To collect and store blood, serum, tissue, urine, or tumor samples of children who have cancer or adults who have common childhood cancers. Eligibility: - Individuals who have been diagnosed with a common childhood cancer (e.g., leukemia) regardless of patient age. - Children, adolescents, and adults who have been diagnosed with a type of cancer more commonly found in adults. Design: - Extra blood, serum (the liquid part of blood), tissue, urine, or tumor samples will be collected from participants at a time when sampling is required for medical care or as part of a research study. - No additional procedures will be performed for the sole purpose of obtaining additional tumor tissue, aside from what is required for clinical care.

NCT ID: NCT01005654 Recruiting - Neuroblastoma Clinical Trials

Prospective Comprehensive Molecular Analysis of Endocrine Neoplasms

Start date: October 7, 2009
Phase:
Study type: Observational

Background: - Endocrine neoplasms (tumors) are among the fastest growing tumors in incidence in the United States. Furthermore, it is often difficult to distinguish between benign or malignant tumors in cancers of the thyroid, parathyroid, adrenal gland, and pancreas. More research is needed to improve detection and treatment options for patients who develop these kinds of cancer. - Researchers are interested in studying the molecular changes that are involved in endocrine cancer development and growth. To collect a sample of tumor specimens and healthy tissue for further study, researchers are specifically looking for samples from patients who are scheduled for surgery or biopsy on endocrine tumors. Objectives: - To collect samples of precancerous, cancerous, and healthy tissue from individuals who are scheduled for surgery or biopsy of endocrine system tumors. Eligibility: - Individuals who have a tumor in or around their thyroid, parathyroid, adrenal gland, pancreas, or any neuroendocrine tissue, and are scheduled for surgery at the National Institutes of Health Clinical Center. Design: - Participants in this study will provide blood and urine samples prior to surgery. - During the surgery or biopsy, pieces of the tumor or precancerous growth and pieces of normal tissue near to the tumor will be removed for ongoing and future research. The rest of the tumor or growth will be sent for analysis. - After surgery, participants will receive routine care until discharge, and doctors will discuss possible treatment options. If there is an appropriate NIH protocol, participants may choose to be treated at the NIH. - After discharge, participants will return to the clinic for a routine postoperative check about 6 weeks following the operation, and then may be followed yearly at the Clinical Center or by phone.

NCT ID: NCT00939965 Recruiting - Neuroblastoma Clinical Trials

Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

Start date: February 2009
Phase: N/A
Study type: Interventional

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors plan better treatment for patients receiving isotretinoin. PURPOSE: This clinical trial is studying the side effects and best dose of isotretinoin in treating young patients with high-risk neuroblastoma.

NCT ID: NCT00904241 Recruiting - Clinical trials for Ganglioneuroblastoma

Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

Start date: November 6, 2000
Phase:
Study type: Observational

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

NCT ID: NCT00898755 Recruiting - Lymphoma Clinical Trials

Collecting and Storing Tissue From Young Patients With Cancer

Start date: March 5, 2007
Phase:
Study type: Observational

This laboratory study is collecting and storing tissue, blood, and bone marrow samples from young patients with cancer. Collecting and storing samples of tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.