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  4. 4. Assurance qualité
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Geselecteerde datamodellen

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99 Zoekresultaten.
Relevantie Beoordeling Nieuwe eerst Oude eerst

Recurring cancer children (ADVL0212 NCT00053963) - Reporting Period Worksheet cancer (NCT00053963)

- 22/03/2015 - 1 Formulier, 5 Itemgroepen, 58 Data-elementen, 1 Taal
Itemgroepen: Header, Patient characteristics, Concomitant Medication, Patient status, Adverse event
ADVL0212: Reporting Period Worksheet FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia NCT00053963 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC15B1-1989-311F-E034-0003BA12F5E7

Pharmacokinetic Study of Doxorubicin in Children With Cancer DRKS00003787 NCT01095926 - 1st Sampling period

- 27/09/2021 - 2 Formulieren, 20 Itemgroepen, 113 Data-elementen, 1 Taal
Itemgroepen: Physical Examination, Determination of cardiac function (before sampling period), Clinical chemistry, Haematology, Agents that are known to interact with doxorubicin according to SmPCs administered?, Antiemetic agents administered?, Cardioprotective agents administered?, Systemic antimycotic agents, Other agents administered?, Actual protocol block, Start of actual protocol block, Chemotherapy in actual protocol block administered ?, Previous anthracycline treatment, Doxorubicin treatment in 1st sampling period, Haematological toxicity of actual protocol block, Transfusions, Determination of cardiac function (end of sampling period), Adverse events, Start of next protocol block, Footer module
Official Title: Phase II Pharmacokinetic Study to Assess the Age-dependency in the Clearance of Doxorubicin in Paediatric Patients With Solid Tumours and Leukaemia Analyze pharmacokinetics of doxorubicin in children with cancer. Furthermore investigate the predictive role of troponin and natriuretic peptides for anthracycline-induced cardiotoxicity. https://clinicaltrials.gov/ct2/show/NCT01095926 NCT01095926

Registration

6 Itemgroepen 25 Data-elementen

dbGaP phs000720 Genomic sequencing of Pediatric Rhabdomyosarcoma - Eligibility

- 29/01/2025 - 5 Formulieren, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: IG.elig
Principal Investigator: Javed Khan, MD, National Institutes of Health, Bethesda, MD, USA MeSH: Rhabdomyosarcoma,Rhabdomyosarcoma, Alveolar,Rhabdomyosarcoma, Embryonal https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000720 Rhabdomyosarcoma (RMS) is the most common soft tissue sarcoma of childhood accounting for approximately 350 newly diagnosed cases yearly in the United States. With the development of multimodal chemotherapy regimens, relapse-free survival rates have improved to 70-80% in patients with localized disease albeit with significant toxicity. Unfortunately, despite aggressive treatment, patients with metastatic or recurrent disease continue to suffer from high mortality. Further characterization of the genetic events underlying this tumor type is critical for the development of more effective diagnostic, prognostic and therapeutic strategies. In a collaborative effort between the National Cancer Institute, the Children's Oncology Group, and the Broad Institute, we use a combination of whole-genome and whole-exome sequencing to characterize the landscape of somatic alterations in 147 tumor/normal pairs.

pht003878.v2.p1

1 Itemgroep 3 Data-elementen

pht003879.v4.p1

1 Itemgroep 3 Data-elementen

pht003881.v2.p1

1 Itemgroep 7 Data-elementen

pht003880.v2.p1

1 Itemgroep 5 Data-elementen

Refractory tumors in children (NCT00053963) - Eligibility Worksheet (ADVL0212 NCT00053963)

- 20/03/2015 - 1 Formulier, 2 Itemgroepen, 32 Data-elementen, 1 Taal
Itemgroepen: Header, Eligibility criteria
ADVL0212: Eligibility Worksheet FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia NCT00053963 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC07E8-6588-30D1-E034-0003BA12F5E7

dbGaP phs000614 Genomic Analysis of Pediatric Low Grade Gliomas - Eligibility

- 04/12/2022 - 6 Formulieren, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: IG.elig
Principal Investigator: Keith L. Ligon, MD, PhD, Dana-Farber Cancer Institute, Boston Children's Hospital, MA, USA MeSH: Astrocytoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000614 Pediatric low-grade gliomas (PLGGs) are among the most common solid tumors in children but, apart from mutations or duplications in the BRAF kinase in specific subclasses, few genetic driver events are known. Diffuse PLGGs compose a set of uncommon subtypes that exhibit invasive growth and are therefore especially challenging clinically. These tumors are particularly poorly understood. We performed high-resolution copy-number analysis of 44 diffuse PLGGs to identify recurrent alterations. Diffuse PLGGs exhibited fewer such alterations than adult low-grade gliomas, but we identified several significantly recurrent events. The most significant event, 8q13.1 gains, was observed in 28% of diffuse astrocytoma WHO grade II (DA2) and resulted in partial duplication of the transcription factor MYBL1 with truncation of its C-terminal negative-regulatory domain. A similar recurrent deletion-truncation breakpoint was identified in two angiocentric gliomas in the related gene MYB on 6q23.3. Whole genome sequencing of a MYBL1-rearranged diffuse astrocytoma grade II demonstrated MYBL1 tandem duplication and few other events. Two truncated MYBL1 transcripts identified in this tumor induced anchorage-independent growth when expressed in 3T3 cells and tumor formation in nude mice. Truncated transcripts were also expressed in two additional tumors with MYBL1 partial duplication. Our results define clinically relevant molecular subclasses of diffuse PLGGs and highlight a potential role for the MYB family in the biology of low-grade gliomas. "Reprinted from www.pnas.org/cgi/doi/10.1073/pnas.1300252110 with permission from PNAS."

pht003287.v1.p1

1 Itemgroep 2 Data-elementen

pht003288.v1.p1

1 Itemgroep 3 Data-elementen

pht003289.v1.p1

1 Itemgroep 2 Data-elementen

pht003290.v1.p1

1 Itemgroep 3 Data-elementen

pht003291.v1.p1

1 Itemgroep 7 Data-elementen

dbGaP phs000508 Genomic Sequencing of Pediatric Rhaboid Cancers - pht002809.v1.p1

- 17/10/2022 - 4 Formulieren, 1 Itemgroep, 2 Data-elementen, 1 Taal
Itemgroep: pht002809
Principal Investigator: Charles Roberts, MD, PhD, Dana Farber Cancer Institute, Boston MA, USA MeSH: Rhabdoid Tumor https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000508 In this study, we sequenced the exomes of 35 rhabdoid tumors, highly aggressive cancers of early childhood. This study is part of a larger effort to characterize pediatric cancers as part of the Slim Initiative for Genomic Medicine (SIGMA) project.

pht002811.v1.p1

1 Itemgroep 4 Data-elementen

pht002812.v1.p1

1 Itemgroep 5 Data-elementen

pht002810.v1.p1

1 Itemgroep 3 Data-elementen

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

- 20/09/2021 - 16 Formulieren, 16 Itemgroepen, 68 Data-elementen, 1 Taal
Itemgroepen: 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 Itemgroepen 68 Data-elementen

Therapy and toxicity cycle 1-3

16 Itemgroepen 68 Data-elementen

Therapy and toxicity cycle 4-6

16 Itemgroepen 68 Data-elementen

Therapy and toxicity cycle 7-9

16 Itemgroepen 68 Data-elementen

Baseline

13 Itemgroepen 77 Data-elementen

Reference

12 Itemgroepen 111 Data-elementen

Master Data Pediatric Hematology and Oncology UK Muenster

- 15/12/2016 - 1 Formulier, 3 Itemgroepen, 36 Data-elementen, 2 Talen
Itemgroepen: Medical history, Complications, recurrent disease
Freigabe zur Verarbeitung durch Frau Prof. Rössig, Quellenangabe: "Pädiatrische Hämatologie und Onkologie, UKM" Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Münster Released for adaption by Frau Prof. Rössig Source:Pediatric Hematology und Oncology, University hospital Münster

Master Data Pediatric Hematology and Oncology UK Muenster

- 15/12/2016 - 1 Formulier, 3 Itemgroepen, 34 Data-elementen, 2 Talen
Itemgroepen: Medical history, Complications, recurrent disease
Freigabe zur Verarbeitung durch Frau Prof. Rössig, Quellenangabe: "Pädiatrische Hämatologie und Onkologie, UKM" Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Münster Released for adaption by Frau Prof. Rössig Source:Pediatric Hematology und Oncology, University hospital Münster

dbGaP phs001054 Genomic Characterization of Pediatric Low-Grade Gliomas - Eligibility

- 23/06/2023 - 5 Formulieren, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: IG.elig
Principal Investigator: Adam Resnick, PhD, The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, PA, USA MeSH: Glioma,Astrocytoma https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001054 Pediatric low-grade gliomas (PLGGs) are the most common pediatric brain-tumor, with more than ten histologic subtypes recognized by the World Health Organization. We performed a genomic analysis of 230 PLGGs of which 73 had whole genome/RNA sequencing performed and show that MYB-QKI fusions define the seizure associated tumor, Angiocentric Glioma (AG). MYB-QKI fusions present in AGs contribute to tumorigenesis through three mechanisms: MYB activation by truncation, enhancer translocation driving aberrant MYB-QKI expression, and hemizygous loss of QKI, a tumor suppressor gene. Such interplay between three oncogenic mechanisms has diagnostic and therapeutic implications in AGs, and illustrates the functional complexity associated with rearrangements in cancer.

pht005276.v1.p1

1 Itemgroep 2 Data-elementen

pht005277.v1.p1

1 Itemgroep 3 Data-elementen

pht005278.v1.p1

1 Itemgroep 2 Data-elementen

pht005279.v1.p1

1 Itemgroep 6 Data-elementen

dbGaP phs001228 Kids First Pediatric Research Program in Susceptibility to Ewing Sarcoma Based on Germline Risk and Familial History of Cancer - Eligibility

- 16/05/2023 - 3 Formulieren, 1 Itemgroep, 1 Data-element, 1 Taal
Itemgroep: IG.elig
Principal Investigator: Joshua D. Schiffman, MD, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA MeSH: Sarcoma, Ewing,Neoplasms https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs001228 The Gabriella Miller Kids First Pediatric Research Program (Kids First) is a trans-NIH effort initiated in response to the 2014 Gabriella Miller Kids First Research Act and supported by the NIH Common Fund. This program focuses on gene discovery in pediatric cancers and structural birth defects and the development of the Gabriella Miller Kids First Pediatric Data Resource (Kids First Data Resource). Ewing sarcoma (EWS) is a deadly bone cancer that occurs in children and adolescents. Mounting evidence suggests that a genetic predisposition exists for this pediatric cancer, although the specific genetic contribution has yet to be identified. EWS has never been linked to a specific cancer predisposition syndrome, although several case reports have been published that describe siblings and cousins with EWS. Furthermore, neuroectodermal tumors appear to occur more commonly in families with EWS. The two consistent epidemiology findings in EWS include a very strong Caucasian predilection and increased rates of hernia in EWS patients and their family members. Finally, the role of genetic microsatellite repeats in EWS tumorigenesis has been recently described, and these GGAA microsatellites are polymorphic in repeat size and location across the genome. The study goals of this Kids First project include (1) To identify cancer predisposition genes in EWS trios increasing disease risk, (2) To identify genome-wide GGAA microsatellite repeats in EWS trios increasing disease risk, and (3) To identity de novo mutation and structural variant rates in EWS trios reflecting underlying DNA repair defects that increase disease risk. As part of the Kids First Common Fund initiative, this study proposal will further elucidate the genetic contribution to pediatric cancer development. Around 375 of these trios were selected for whole genome sequencing as part of the Gabriella Miller Kids First fund. The EWS trios have been collected as part of the Children's Oncology Group's AEPI10N5 Study ("Genetic Epidemiology of Ewing Sarcoma"), and each trio has associated phenotypic data including a detailed family history. We will interrogate the sequence data using our genomic analysis pipeline at the University of Utah and the Utah Science Technology and Research initiative's (USTAR) Center for Genetic Discovery. We will look for the genetic contribution to ES and the sequence data with be shared in a repository designated by the Kids First Common Fund. All of the WGS and phenotype data from this study is accessible through kidsfirstdrc.org, where other Kids First datasets can also be accessed. The WGS of these ~375 EWS trios will help us to understand the genetic origins of a deadly childhood cancer and may lead to novel strategies for prevention and treatment.

pht008133.v1.p1

1 Itemgroep 2 Data-elementen

pht008134.v1.p1

1 Itemgroep 2 Data-elementen

Pediatric oncology brain tumor tumor board Oncology Form University Hospital Cologne

- 08/05/2017 - 1 Formulier, 1 Itemgroep, 30 Data-elementen, 1 Taal
Itemgroep: Pediatric oncology brain tumor tumor board request
Pediatric oncology brain tumor tumor board request form at the endocrinology polyclinic department University Hospital Cologne. Asking questions regarding basic patient information, tumor board organisation, diagnosis and comorbidity, pathology and tumor staging as well as diagnostic imaging. ODM derived from routine documentation of University Hospital Cologne.

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