ClinicalTrials.gg
RecruitingNCT01109394Updated Oct 16, 2026

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

An observational study in Sarcoma, Endocrine Tumors and Neuroblastoma, sponsored by National Cancer Institute (NCI). Recruiting at 5 sites in United States. Open to participants aged 4 Weeks and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by National Cancer Institute (NCI) · Observational

From the registry’s dates

  • Started Apr 2010; still recruiting 16 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
6,035
Ages
4 Weeks and older
Sex
All
01

Study 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.
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.
02

Conditions studied

  • Sarcoma
  • Endocrine Tumors
  • Neuroblastoma
  • Retinoblastoma
  • Renal Cancer

Keywords

  • Genomics
  • Proteomics
  • Tissue Repository
  • Omics
  • Cell Lines
  • Natural History
  • Pediatric Cancer
  • Solid Tumor
  • Sarcoma
  • Kidney Cancer
  • Neuroblastoma
03

In context

Sarcoma

1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.

This study's planned enrollment of 6,035 is above the median of 120 across 218 observational studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Weeks and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Eligibility criteria

  • SUBJECT INCLUSION CRITERIA:

Pediatric or adult subjects with one of the following:

  • Diagnosis of any tumor, , 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 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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
6,035 participants (estimated)

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. tissue analysis

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

    Time frame: ongoing

07

Study locations

1 of 5 sites recruiting
  • Children's National Medical Center
    Washington D.C., District of Columbia 20010, United States
    Completed

    Not enrolling at this site.

  • Children's Hospital of Orange County (CHOC Children's)
    Orange, Florida 92613, United States
    Withdrawn

    Not enrolling at this site.

  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
  • Tisch Cancer Institute, Mount Sinai Medical Center
    New York, New York 10029-0574, United States
    Withdrawn

    Not enrolling at this site.

  • Carolinas Medical Center/Levine Children's Hospital
    Charlotte, North Carolina 28203, United States
    Withdrawn

    Not enrolling at this site.

08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT01109394
Responsible party
Sponsor
First posted
Apr 23, 2010
Start date
Apr 21, 2010
Last update
Oct 16, 2026

Study contacts

Donna B Bernstein, R.N.
Contact
bernsted@mail.nih.gov
(240) 760-6189
Rosandra N Kaplan, M.D.
Contact
kaplanrn@mail.nih.gov
(240) 760-6198
Rosandra N Kaplan, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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