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 : June 21, 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|
Show Detailed Description
|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 ]Perform systematic molecular, genomic, proteomic, metabolomics and other high throughput ("Omics") profiling on tumor and normal tissues
- Tissue repository [ Time Frame: 1 year ]Create a tissue repository designed to allow blood, serum, plasma, urine, stool, buccal swabs, bone marrow, CSF, malignant ascites and malignant effusions, normal tissue and tumor sample collection and storage for use in the study of patients with or without a malignancy. Human samples, specimens and data collected on IRB approved protocols that are now terminated may be transferred for continued analysis and new research without additional risk, on this study.
- Growth factors & cellular profile analysis [ Time Frame: 1 year ]Investigate the growth factor and cellular profile of different pediatric and adult malignancies and correlate this with disease course by measuring circulating levels of circulating tumor cells, growth factors, microvesicles, cell free DNA and bone marrow- derived cells including immune cells, HPCs, EPCs, MPCs and 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.
- Establish cell lines & Xenografts (tumor and normal lymphocytes) [ Time Frame: 1 year ]Establish cell lines and Xenografts from tumor samples and cell lines from normal cells.
- Oversight committee [ Time Frame: 1 year ]Create an oversight committee to oversee a variety of laboratory investigations designed to support NIH translational studies, to apply new methodologies in the investigation of cellular, molecular, genetic, and genomic biology, to probe for new therapeutic targets, and to develop new treatment approaches.
- Identify caregiver attitudes regarding NGS [ Time Frame: 1 year ]Identify caregiver attitudes toward the use of next generation sequencing (NGS) for diagnosing and managing pediatric cancer and the return of NGS genetic test results and incidental findings to caregivers.
- QOL vs impact of NGS genetic test results [ Time Frame: 1 year ]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 patients, caregivers and the family system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109394
|Contact: Donna M Bernstein, R.N.||(240) email@example.com|
|Contact: Rosandra N Kaplan, M.D.||(301) firstname.lastname@example.org|
|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)|