Clinical Trial Finder

• - SUBJECT

  INCLUSION CRITERIA:

  Pediatric or adult subjects with one of the following: - Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected premalignant familial syndromes, regardless, of patient age; - Biological relatives of any patients with tumor, malignancy, premalignant disorder, or suspected familial pre-malignant syndrome, regardless of patient age or the diagnosis of an adult malignancy or pre-malignant disorder; - Healthy Volunteer without history of malignancy nor a family member currently being treated for cancer who are undergoing surgery, treatment or during well visits; - Biospecimens can be collected with minimal additional risk to the subject during sampling or procedures required for routine patient care.

• - Human samples, specimens and data collected on IRB approved protocols that are now closed.

• - Ability of subject, Legally Authorized Representative (LAR), or parent/legal guardian of children less than or equal to 18 to understand and be willing to sign an IRB-approved informed consent document that permits the use of the tumor and other samples for genomic-based molecular characterization projects.

• - Parent/caregiver of a participating pediatric or adult patient who is being treated for, or who has previously been treated for any form of pediatric cancer.

• - Must be able to give consent and sign the informed consent document.

• - Able to understand the English language.

EXCLUSION CRITERIA:

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.

• - 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.

Arms

Interventions