Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies
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|ClinicalTrials.gov Identifier: NCT01109394|
Recruitment Status : Recruiting
First Posted : April 23, 2010
Last Update Posted : February 14, 2018
- 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.
- To collect and store blood, serum, tissue, urine, or tumor samples of children who have cancer or adults who have common childhood cancers.
- 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.
- 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.
|Condition or disease|
|Sarcoma Endocrine Tumors Neuroblastoma Retinoblastoma Renal Cancer|
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-Laboratory-based investigations have contributed to an improved understanding of the biology of cancer and to the development of new therapies for pediatric malignancies.
- Systematic Molecular, Genomic, Proteomic, Metabolomic ( Omic ) and other profiling for consenting patients enrolled at the Pediatric Oncology Branch, Children s National Medical Center (CNMC), Carolinas Medical Center/Levine Children s Hospital, and collaborative institutions.
- Establish a sample acquisition protocol for the collection and banking of pediatric solid tumors and paired normal tissue to support research conducted by the collaborative studies at the NIH, Children s National Medical Center (CNMC), Carolinas Medical Center/Levine Children s Hospital, and other extramural institutions. Human samples, specimens and data collected on IRB approved protocols that are now terminated may be transferred for continued analysis and new research on this study.
- Investigate the growth factor and cellular profile of different pediatric and adult malignancies and correlate this with disease course by measuring circulating levels of growth factors, microvesicles and bone marrow-derived cells including hematopoietic progenitor cells (HPCs), endothelial progenitor cells (EPCs), mesenchymal progenitor cells (MPCs) and matrix metalloproteases (MMPs) in the blood and urine of pediatric and adult patients without malignancy, as well as patients with pediatric and adult malignancies, and determining if these levels predict development of metastasis, or change during treatment, such as when undergoing surgery, chemotherapy and other treatments such as immunotherapy.
- Identify caregiver attitudes toward the use of next generation sequencing (NGS) at the NIH for diagnosing and managing pediatric cancer and the return of NGS genetic test results and incidental findings to caregivers.
- Evaluate the anticipated short- and long-term impact of returning NGS genetic test results for cancer and incidental findings on quality of life and related bioethical outcomes among NIH patients, caregivers, and the family system.
- Subjects with a diagnosis of any tumor or malignancy regardless of age, or without malignancy undergoing surgery, other treatment or normal well visit.
- Suspicion of a familial premalignant condition.
- Biological relatives of a subject with a pediatric tumor or malignancy or with suspected familial cancer syndrome.
- Biological relatives of a subject with an adult tumor or malignancy or with suspected familial cancer syndrome.
- Blood and/or tissue specimens that have been previously collected and are available for study or that can be collected with minimal additional risk to the subject during sampling required for routine patient care.
- This study will allow for the collection of specimens for a Tissue Repository, and for designated sample investigations including systematic molecular, genomic and proteomic (Omic) profiling, and growth factor and cellular profile investigations.
- Specimens will be collected and stored at the Advanced Technology Center, Gaithersburg, MD
- Linked clinical and demographic data will be stored in the HIPAA compliant, secure web-based database (Labmatrix).
Testing activities may include:
- DNA, RNA and protein will be extracted from a section of tumor samples, the remainder will be stored.
- Germ line DNA and RNA will be extracted from lymphocytes or other normal uninvolved tissue
- Germ line DNA will be extracted from lymphocytes or other normal uninvolved tissue of the biological relatives of the subject.
- Xenografts and cell lines will be established from tumor samples
- Blood and/or Bone Marrow will be sent to Coriell Institute for Medical Research for the establishment of EBV transformed cell lines.
- Tumor samples sent to Molecular Response for the establishment of Xenografts and single cell suspension of tumor for drug testing
- Omics (Genomics and Proteomic) studies will be performed
- Growth factor and cellular profile investigations of bone marrow-derived cell populations to include quantification of hematopietic progenitor cells (HPCs), endothelial progenitor cells (EPCs), and mesenchymal progenitor cells (MPCs), levels of matrix metalloprotease 2 and 9 (MMP2) and (MMP9), gene expression, growth factor and microvesicle analysis and bone marrow analysis of progenitor cells in blood and tissue.
- Research tests described in IRB approved protocols (terminated) (including 97-C-0050,97-C-0052, 00-C-0092, 02-C-0259, 07-C-0040, 08-C-0007, 13-C-0152.
- Establishing an oversight committee to oversee the receipt and the distribution of unlinked tissues to other investigators.
- Qualitative methodologies will be used to ascertain knowledge, attitudes, beliefs, and behaviors in 25-35 parents/caregivers at NIH concerning the anticipated use of NGS for diagnosing and directing therapy for pediatric cancer and how incidental findings might be returned.
- Expected accrual 50-100 patients per year per center equaling approximately 150 patients
enrolled per year. Total protocol accrual goal 2,000 patients and 4000 biologic relatives, and up to 35 caregivers, for a total of 6035 participants.
|Study Type :||Observational|
|Estimated Enrollment :||6035 participants|
|Official Title:||Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies|
|Study Start Date :||April 19, 2010|
- Tissue analysis [ Time Frame: ongoing ]
- Tissue repository [ Time Frame: 1 year ]
- Growth factors & cellular profile analysis [ Time Frame: 1 year ]
- Establish cell lines & Xenografts (tumor and normal lymphocytes) [ Time Frame: 1 year ]
- Oversight committee [ Time Frame: 1 year ]
- Identify caregiver attitudes regarding NGS [ Time Frame: 1 year ]
- QOL vs impact of NGS genetic test results [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109394
|Contact: Amanda M Carbonell||(301) firstname.lastname@example.org|
|Contact: Rosandra N Kaplan, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937|
|Principal Investigator:||Rosandra N Kaplan, M.D.||National Cancer Institute (NCI)|