Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies
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|ClinicalTrials.gov Identifier: NCT01109394|
Recruitment Status : Recruiting
First Posted : April 23, 2010
Last Update Posted : May 30, 2018
|First Submitted Date||April 22, 2010|
|First Posted Date||April 23, 2010|
|Last Update Posted Date||May 30, 2018|
|Study Start Date||April 19, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Tissue analysis [ Time Frame: ongoing ]
Perform systematic molecular, genomic, proteomic, metabolomics and other high throughput ("Omics") profiling on tumor and normal tissues
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01109394 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies|
|Official Title||Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies|
- 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.
- To collect and store blood, serum, tissue, urine, or tumor samples of children who have cancer or adults who have common childhood cancers.
-Laboratory-based investigations have contributed to an improved understanding of the biology of cancer and to the development of new therapies for pediatric malignancies.
enrolled per year. Total protocol accrual goal 2,000 patients and 4000 biologic relatives, and up to 35 caregivers, for a total of 6035 participants.
|Study Design||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||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.|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
Pediatric or adult patients with one of the following:
Individual may be undergoing treatment for malignancy or other health problem.
Informed consent or IRB waiver of the requirement for informed consent for specific types of tissue as detailed.
|Ages||up to 99 Years (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||100086
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )|
|Study Sponsor||National Cancer Institute (NCI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 24, 2018|