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SarcomaNCT01109394

Comprehensive Omics Analysis of Pediatric and Adult Solid Tumors and Establishment of a Repository for Related Biological Studies

An observational study of Sarcoma and Endocrine Tumors, run by National Cancer Institute (NCI) at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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. Read more about this study

Who is it for?
Ages 4 weeks and olderHealthy volunteers can take part
Conditions the study is for
Sarcoma, Endocrine Tumors, Neuroblastoma
How many people
6,035 participants
Where
5 sitesUnited States
Study dates
21 Apr 2010to not given
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 weeks and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

None listed.

Who cannot join

  • None

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

5 sites in 1 country

United States5 sites, 1 recruiting
  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

    For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov

    Recruiting
  • Carolinas Medical Center/Levine Children's Hospital

    Charlotte, North Carolina, 28203

    Withdrawn
  • Tisch Cancer Institute, Mount Sinai Medical Center

    New York, New York, 10029-0574

    Withdrawn
  • Children's Hospital of Orange County (CHOC Children's)

    Orange, Florida, 92613

    Withdrawn
  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

    Completed

Other trials in United States

About this study

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.
Read more

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.
Read the detailed 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 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:

  • 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 such as apheresis or normal well visit or routine blood draw as part of standard of care.
  • Biological relatives of a subject with a tumor or malignancy (pediatric or adult) 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 extracted from a section of tumor and normal samples; the remainder will be stored.
  • Germ line DNA and RNA extracted from lymphocytes or other normal uninvolved tissue
  • Germ line DNA will be extracted from lymphocytes or other normal uninvolved tissue of 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 or for monitoring cell free DNA over time
  • Omics (Genomics and Proteomic) studies will be performed
  • Growth factor and cellular profile investigations of bone marrow-derived cell populations to include quantification of hematopoietic 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 of 100-150 patients per year.
Keywords
Genomics, Proteomics, Tissue Repository, Omics, Cell Lines, Natural History, Pediatric Cancer, Solid Tumor, Sarcoma, Kidney Cancer, Neuroblastoma
Medical subject headings
Sarcoma, Neuroblastoma, Retinoblastoma, Kidney Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01109394
Study groupRoleWhat they receive
1/Cohort 1Adult or Pediatric subjects, with any malignancy, pre-malignancy, suspected malignancy, family history of malignancy, or without malignancy undergoing surgery or well visit.
2/Cohort 2Human samples, specimens and data collected on IRB approved protocols that are now closed
3/Cohort 3Parent/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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. tissue analysis

    Perform systematic molecular, genomic, proteomic, metabolomics and other high throughput ( Omics ) profiling on tumor and normal tissues

    Measured: ongoing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2010 (estimated)
  2. Study start21 Apr 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
6,035 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01109394
Sponsor's protocol ID
100086
Other IDs
10-C-0086
Status last verified
13 Oct 2026
First submitted
22 Apr 2010
Last updated
16 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 10379968
  • 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.

    PubMed 10214349
  • 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.

    PubMed 10197427

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