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.
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
- Are there results?
- Not yet: the study is under way
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.
5 sites in 1 country
United States5 sites, 1 recruiting
- 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
- Withdrawn
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- Withdrawn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- Withdrawn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
- Completed
Children's National Medical Center
Washington D.C., District of Columbia, 20010
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.
- Conditions
- 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
- 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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted23 Apr 2010 (estimated)
- Study start21 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rosandra N Kaplan, M.D., Principal investigator, National Cancer Institute (NCI)
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 10379968Khan 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 10214349Khan 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Omics Analysis of Pediatric and Adult Solid Tumors and Establishment of a Repository for Related Biological Studies
- ClinicalTrials.gov ID
- NCT01109394
- Acronym / sponsor ID
- 100086
- Conditions
- Sarcoma, Endocrine Tumors, Neuroblastoma, Retinoblastoma, Renal Cancer
- Keywords
- Genomics, Proteomics, Tissue Repository, Omics, Cell Lines, Natural History, Pediatric Cancer, Solid Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,035 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 21 Apr 2010 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 4 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
tissue analysis
Time frame: ongoing
Perform systematic molecular, genomic, proteomic, metabolomics and other high throughput ( Omics ) profiling on tumor and normal tissues
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 10379968Linet 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.
- Background: PubMed 10214349Khan 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.
- Background: PubMed 10197427Khan 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rosandra N Kaplan, M.D. principal investigator
National Cancer Institute (NCI)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma and Endocrine Tumors, run by National Cancer Institute (NCI) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donna B Bernstein, R.N. ((240) 760-6189, bernsted@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tissue analysis (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01109394, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.