Comprehensive Omics Analysis of Pediatric and Adult Solid Tumors and Establishment of a Repository for Related Biological Studies
2 other identifiers
observational
6,035
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 21, 2010
CompletedFirst Submitted
Initial submission to the registry
April 22, 2010
CompletedFirst Posted
Study publicly available on registry
April 23, 2010
CompletedApril 24, 2026
September 25, 2025
April 22, 2010
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tissue analysis
Perform systematic molecular, genomic, proteomic, metabolomics and other high throughput ( Omics ) profiling on tumor and normal tissues
ongoing
Study Arms (3)
1/Cohort 1
Adult or Pediatric subjects, with any malignancy, pre-malignancy, suspected malignancy, family history of malignancy, or without malignancy undergoing surgery or well visit.
2/Cohort 2
Human samples, specimens and data collected on IRB approved protocols that are now closed
3/Cohort 3
Parent/caregiver of a participating pediatric or adult subject who is being treated for, or who has previously been treated for any form of pediatric cancer.
Eligibility Criteria
Subjects with a diagnosis of any tumor or malignancy regardless of age, or without malignancy undergoing surgery, other treatment or normal well visit. Suspicion of a familial premalignant condition. Biological relatives of a subject with a pediatric or adult tumor or malignancy or with suspected familial cancer syndrome.
You may qualify if:
- 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 patient with a tumor, malignancy, pre-malignant 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 \<=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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Children's Hospital of Orange County (CHOC Children's)
Orange, Florida, 92613, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Tisch Cancer Institute, Mount Sinai Medical Center
New York, New York, 10029-0574, United States
Carolinas Medical Center/Levine Children's Hospital
Charlotte, North Carolina, 28203, United States
Related Publications (3)
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.
PMID: 10379968BACKGROUNDKhan 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.
PMID: 10214349BACKGROUNDKhan 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.
PMID: 10197427BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rosandra N Kaplan, M.D.
National Cancer Institute (NCI)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2010
First Posted
April 23, 2010
Study Start
April 21, 2010
Last Updated
April 24, 2026
Record last verified: 2025-09-25
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
- Access Criteria
- Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.
All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.