Sarcoma Clinical Trial
Official title:
Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies
NCT number | NCT01109394 |
Other study ID # | 100086 |
Secondary ID | 10-C-0086 |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 21, 2010 |
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.
Status | Recruiting |
Enrollment | 6035 |
Est. completion date | |
Est. primary completion date | |
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
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
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 |
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