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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01109394
• Other study ID #: 100086
• Secondary ID: 10-C-0086
• Status: Recruiting
• Start date: April 21, 2010

Study information

• Verified date: June 10, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Donna B Bernstein, R.N.
• Phone: (240) 760-6189
• Email: bernsted[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6035
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Weeks and older

Eligibility

• 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.

Inclusion Criteria for Social and Behavioral Outcome Interviews:

• 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:

None

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland
United States	Carolinas Medical Center/Levine Children's Hospital	Charlotte	North Carolina
United States	Tisch Cancer Institute, Mount Sinai Medical Center	New York	New York
United States	Children's Hospital of Orange County (CHOC Children's)	Orange	Florida
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Khan J, Bittner ML, Chen Y, Meltzer PS, Trent JM. DNA microarray technology: the anticipated impact on the study of human disease. Biochim Biophys Acta. 1999 Mar 25;1423(2):M17-28. doi: 10.1016/s0304-419x(99)00004-9. — View Citation

Khan J, Saal LH, Bittner ML, Chen Y, Trent JM, Meltzer PS. Expression profiling in cancer using cDNA microarrays. Electrophoresis. 1999 Feb;20(2):223-9. doi: 10.1002/(SICI)1522-2683(19990201)20:23.0.CO;2-A. — View Citation

Linet MS, Ries LA, Smith MA, Tarone RE, Devesa SS. Cancer surveillance series: recent trends in childhood cancer incidence and mortality in the United States. J Natl Cancer Inst. 1999 Jun 16;91(12):1051-8. doi: 10.1093/jnci/91.12.1051. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tissue analysis	Perform systematic molecular, genomic, proteomic, metabolomics and other high throughput ( Omics ) profiling on tumor and normal tissues	ongoing

External Links

•   NIH Clinical Center Detailed Web Page