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| ID | Type | Description | Link |
|---|---|---|---|
| 10-C-0086 |
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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:
Design:
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 where omics refers to mechanistic studies using a set of advanced technologies to capture comprehensive aspects of biological systems providing insights into structure, function and interactions to understand these complex processes and diseases better.
Eligibility:
Pediatric or Adult subjects of any age with one of the following:
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:
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 of 100-150 patients per year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| tissue analysis | Perform systematic molecular, genomic, proteomic, metabolomics and other high throughput ( Omics ) profiling on tumor and normal tissues | ongoing |
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Pediatric or adult subjects with one of the following:
Inclusion Criteria for Social and Behavioral Outcome Interviews:
EXCLUSION CRITERIA:
None
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donna B Bernstein, R.N. | Contact | (240) 760-6189 | bernsted@mail.nih.gov | |
| Rosandra N Kaplan, M.D. | Contact | (240) 760-6198 | kaplanrn@mail.nih.gov |
| Name | Affiliation | Role |
|---|---|---|
| Rosandra N Kaplan, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Medical Center | Completed | Washington D.C. | District of Columbia | 20010 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10379968 | Background | 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. | |
| 10214349 | Background | 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. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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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.
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.
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.
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| Children's Hospital of Orange County (CHOC Children's) |
| Withdrawn |
| Orange |
| Florida |
| 92613 |
| United States |
| National Institutes of Health Clinical Center | Recruiting | Bethesda | Maryland | 20892 | United States |
|
| Tisch Cancer Institute, Mount Sinai Medical Center | Withdrawn | New York | New York | 10029-0574 | United States |
| Carolinas Medical Center/Levine Children's Hospital | Withdrawn | Charlotte | North Carolina | 28203 | United States |
| 10197427 | Background | 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. |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D009447 | Neuroblastoma |
| D012175 | Retinoblastoma |
| D007680 | Kidney Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D019572 | Retinal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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