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

Sarcoma Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

Background:

-Laboratory-based investigations have contributed to an improved understanding of the biology of cancer and to the development of new therapies for pediatric malignancies.

Objectives:

-Systematic Molecular, Genomic, Proteomic, Metabolomic ( Omic ) and other profiling for enrolled subjects.

Eligibility:

Pediatric or Adult subjects of any age with one of the following:

• Diagnosis of any tumor or malignancy, pre-malignant disorder or suspected cancer susceptibility familial syndromes, regardless of age

• Individuals without malignancy undergoing surgery, other treatment or normal well visit.

• Biological relatives of a subject with a pediatric tumor or malignancy or with suspected familial cancer syndrome.

• Patients enrolled in an approved companion protocol

• Blood and/or tissue specimens that have been previously collected and are available for research analysis

• Biospecimens can be collected with minimal additional risk to the subject during sampling or procedures required for routine patient care.

Design:

• 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.

• 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, explant and cell lines established from tumor, pre-malignant and normal samples

• Tumor samples and samples for circulating tumor cells sent 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 active IRB approved protocols

• Immune profiling and stromal profiling of blood, tumor, and normal tissues

• Immune function studies from blood and normal tumor tissues

• Utilizing 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 100-150 patients per year. ;

Related Conditions & MeSH terms

• Endocrine Gland Neoplasms
• Endocrine Tumors
• Kidney Neoplasms
• Neuroblastoma
• Renal Cancer
• Retinoblastoma
• Sarcoma

• NCT number: NCT01109394
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Donna B Bernstein, R.N.
• Phone: (240) 760-6189
• Email: bernsted@mail.nih.gov
• Status: Recruiting
• Start date: April 21, 2010