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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
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  6. 6. Patient-Reported Outcome
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dbGaP phs000868 Transcriptome Sequencing of Pediatric Neuroblastoma - Eligibility

- 3/16/24 - 5 forms, 1 itemgroup, 1 item, 1 language
Itemgroup: IG.elig
Principal Investigator: Javed Khan, National Institutes of Health, Bethesda, MD, USA MeSH: Neuroblastoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000868 Neuroblastoma is the most common extra-cranial solid tumor in children. It represents 8% to 10% of all childhood cancers. Stage 4 Neuroblastoma is characterized by its clinical heterogeneous outcome. The special category, stage 4S tumors (2-5% of all NB) are chemo-sensitive, and the patients show spontaneous regression. On the other hand, MYCN amplification (25-30% of all NB) is associated with poor outcome of neuroblastoma, thus we further categorize stage 4 neuroblastoma into MYCN non-amplified and MYCN amplified group. Here we use transcriptome sequencing to characterize the transcriptome in 29 stage 4 Neuroblastoma samples.

pht004587.v1.p1

1 itemgroup 2 items

pht004588.v1.p1

1 itemgroup 3 items

pht004589.v1.p1

1 itemgroup 2 items

pht004590.v1.p1

1 itemgroup 7 items

dbGaP phs001052 Multi-Dimensional ClinOmics for Precision Therapy - Eligibility

- 7/9/23 - 5 forms, 1 itemgroup, 1 item, 1 language
Itemgroup: IG.elig
Principal Investigator: MeSH: Neoplasms,Sarcoma,Sarcoma, Ewing,Rhabdomyosarcoma,Wilms Tumor,Desmoplastic Small Round Cell Tumor,Carcinoma, Transitional Cell,Rhabdoid Tumor,Sarcoma, Synovial,Neuroblastoma,Neuroendocrine tumors https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001052 The Center for Cancer Research (CCR), of the intramural NCI undertook a multidimensional clinical genomics study of children and adolescent young adults with relapsed and refractory cancers who were enrolled on other therapeutic trials to determine the feasibility of a genome guided precision therapy protocol in these patients.

pht005466.v2.p1

1 itemgroup 2 items

pht005467.v2.p1

1 itemgroup 3 items

pht005468.v2.p1

1 itemgroup 3 items

pht005469.v2.p1

1 itemgroup 6 items

dbGaP phs000744 Yale Center for Mendelian Genomics (Y CMG) - pht003977.v4.p2

- 12/11/22 - 5 forms, 1 itemgroup, 5 items, 1 language
Itemgroup: pht003977
Principal Investigator: Richard Lifton, Yale University, New Haven, CT, USA MeSH: Familial Idiopathic Pulmonary Fibrosis,Aortic Coarctation,Aortic Stenosis, Supravalvular,Aortic Valve, Bicuspid,Arteries,Blepharophimosis,Bronchiectasis,Carcinoma, Renal Cell,Cardiomyopathies,Ciliary Motility Disorders,Cleft Palate,Congenital Abnormalities,Diaphragmatic Hernia,Ductus Arteriosus, Patent,Gastroschisis,Heart Defects, Congenital,Heart Septal Defects, Atrial,Heart Valve Diseases,Hemangioma,Hereditary Sensory and Autonomic Neuropathies,Hydrocephalus,Hyper-IgM Immunodeficiency Syndrome,Hyperaldosteronism,Hypertension,Ichthyosiform Erythroderma, Congenital,Idiopathic Pulmonary Fibrosis,Lung Diseases, Interstitial,Muscular Atrophy, Spinal,Neuroblastoma,Pneumothorax,Pulmonary Atresia,Pulmonary Valve Stenosis,Rett Syndrome,Spina Bifida,Tetralogy of Fallot,Transposition of Great Vessels,Tricuspid Atresia https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000744 Yale University is home to one of three national centers created by the NIH to study the genetics of rare inherited diseases. Researchers at Yale, the University of Washington, and a center operated jointly by Baylor and Johns Hopkins University will analyze the genomes of thousands of patients who suffer from more than 6,000 rare Mendelian disorders affecting more than 25 million individuals in US. The Centers for Mendelian Genomics will apply next-generation sequencing and computational approaches to discover the genes and variants that underlie Mendelian disorders. The discovery of new genes that cause Mendelian conditions will expand our understanding about their biology to facilitate their diagnosis, and potentially indicate new treatments. The Centers for Mendelian Genomics will provide free exome sequencing and analysis to collaborating investigators for qualified phenotypes. If you are interested in working with the CMG to discover the genetic basis of a Mendelian condition, please contact Yale Center (shrikant.mane@yale.edu) for further information.

pht003978.v4.p2

1 itemgroup 3 items

pht003979.v4.p2

1 itemgroup 7 items

pht003980.v4.p2

1 itemgroup 2 items

pht003976.v4.p2

1 itemgroup 2 items

dbGaP phs000124 Genome-Wide Association Study of Neuroblastoma - Eligibility

- 10/12/22 - 4 forms, 1 itemgroup, 2 items, 1 language
Itemgroup: IG.elig
Principal Investigator: John M. Maris, Division of Oncology and Center for Childhood Cancer Research, Children's Hospital of Philadelphia; Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, USA MeSH: Neuroblastoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000124 Neuroblastoma is a malignancy of the developing sympathetic nervous system that most commonly affects young children and is often lethal. The etiology of this embryonal cancer is not known. We have performed a whole genome scan for association of neuroblastoma with SNP genotypes and copy number variation to discover predisposition loci. We therefore initiated a genome-wide association study (GWAS) in 2007 focused on neuroblastoma patients identified through the Children's Oncology Group (COG; 238 member institutions). Control patients for this study are children cared for at the Children's Hospital of Philadelphia (CHOP) without a diagnosis of cancer. The study was designed to collect up to 5000 neuroblastoma cases and 10,000 controls and is powered to detect common susceptibility variants in Caucasian and African American patients. Whole genome genotyping is being performed on the Illumina HH550 SNP array.

pht002172.v1.p1

1 itemgroup 2 items

pht002173.v1.p1

1 itemgroup 12 items

pht002171.v1.p1

1 itemgroup 3 items

Metronomic Treatment in Children and Adolescents With Recurrent or Progressive High Risk Neuroblastoma (METRO-NB2012) NCT02641314 - Therapy and toxicity cycle 10-13

- 9/20/21 - 16 forms, 16 itemgroups, 68 items, 1 language
Itemgroups: Therapy cycle 10-13, Therapy after cycle, Propranolol, Propranolol therapy deviation, Celecoxib, Celecoxib deviation, Cyclophosphamide, Cyclophosphamide deviation, Vinblastine, Vinblastine deviation, Toxicity overview, Toxicity, Hospitalization, Comments, Transfusion, Footer module
NCT02641314 Phase 2 Trial of Metronomic Treatment in Children and Adolescents With Recurrent or Progressive Neuroblastoma (NB). The study investigates the tolerance and the efficacy of a new combination of five drugs consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic), etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic, anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are applied daily throughout 365 days (except etoposide for 4x3 weeks). The efficacies of each of the drugs have been demonstrated in vitro and in vivo in animal studies. All drugs have been used in children for other conditions. From those experiences low toxicities and a favorable Quality of life are expected. Prof. Dr. Frank Berthold Abt. für Kinderonkologie und –hämatologie Zentrum für Kinder- und Jugendmedizin Universität zu Köln

Therapy and toxicity cycle > 13

16 itemgroups 68 items

Therapy and toxicity cycle 1-3

16 itemgroups 68 items

Therapy and toxicity cycle 4-6

16 itemgroups 68 items

Therapy and toxicity cycle 7-9

16 itemgroups 68 items

Baseline

13 itemgroups 77 items

Reference

12 itemgroups 111 items

ANBL0321 MIBG Response NCT00053326

- 9/20/21 - 1 form, 5 itemgroups, 6 items, 1 language
Itemgroups: Header, Period Number, Tumor Response, Comments, CCRR MODULE
ANBL0321 MIBG Response NCT00053326 Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B968BED1-43CF-22DE-E034-0003BA12F5E7

ANBL0321: Death Worksheet NCT00053326

- 7/5/15 - 1 form, 3 itemgroups, 17 items, 1 language
Itemgroups: Header, Death Assessment, CCRR MODULE
ANBL0321: Death Worksheet NCT00053326 Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B9B55D16-FD2B-1EE8-E034-0003BA12F5E7

ANBL0321: Prior Therapy Worksheet NCT00053326

- 7/3/15 - 1 form, 7 itemgroups, 21 items, 1 language
Itemgroups: Header, Cancer Prior Treatment, Type of Prior Therapy, Stem cell transplant, Comments, General Validations/Notes, CCRR MODULE
ANBL0321: Prior Therapy Worksheet NCT00053326 Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B92CFA2B-A3FF-34F4-E034-0003BA12F5E7

ANBL0321: Relapse/Progression Worksheet NCT00053326

- 7/3/15 - 1 form, 3 itemgroups, 13 items, 1 language
Itemgroups: Header, Relapse/Progression, CCRR MODULE
ANBL0321: Relapse/Progression Worksheet NCT00053326 Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B968B3D2-B7BF-21FC-E034-0003BA12F5E7

ANBL0321: On Study Worksheet NCT00053326

- 7/3/15 - 1 form, 4 itemgroups, 24 items, 1 language
Itemgroups: Header, Miscellaneous Patient Information, Comments, CCRR MODULE
ANBL0321: On Study Worksheet NCT00053326 Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B9543982-264A-44CD-E034-0003BA12F5E7

ANBL0321: CT/MRI Response Assessment Form NCT00053326

- 7/3/15 - 1 form, 4 itemgroups, 18 items, 1 language
Itemgroups: Header, CT/MRI Response Assessment, New Lesion, CCRR MODULE
ANBL0321: CT/MRI Response Assessment Form NCT00053326 Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B968DB9B-1F21-22F4-E034-0003BA12F5E7

ANBL0321: Pre-Existing Conditions At Time of Study Entry NCT00053326

- 7/3/15 - 1 form, 4 itemgroups, 14 items, 1 language
Itemgroups: Header, Adverse event assessment, Comments, CCRR MODULE
ANBL0321: Pre-Existing Conditions At Time of Study Entry NCT00053326 Fenretinide in Treating Children With Recurrent or Resistant Neuroblastoma Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B9B49D1C-054C-1FC6-E034-0003BA12F5E7

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