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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01109394
Recruitment Status : Recruiting
First Posted : April 23, 2010
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief 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.

Condition or disease
Sarcoma Endocrine Tumors Neuroblastoma Retinoblastoma Renal Cancer

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 6035 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies
Actual Study Start Date : April 21, 2010


Group/Cohort
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.



Primary Outcome Measures :
  1. Tissue analysis [ Time Frame: ongoing ]
    Perform systematic molecular, genomic, proteomic, metabolomics and other high throughput ("Omics") profiling on tumor and normal tissues



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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.
Criteria
  • SUBJECT INCLUSION CRITERIA:

Pediatric or adult subjects with one of the following:

  • Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected premalignant familial syndromes, regardless, of patient age;
  • Biological relatives of any patients with tumor, malignancy, premalignant 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 less than or equal to 18 to understand and be willing to sign an IRB-approved informed consent 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109394


Contacts
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Contact: Donna M Bernstein, R.N. (240) 760-6189 db302w@nih.gov
Contact: Rosandra N Kaplan, M.D. (240) 760-6198 kaplanrn@mail.nih.gov

Locations
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United States, District of Columbia
Childrens National Medical Center Recruiting
Washington, District of Columbia, United States
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    (888) NCI-1937      
United States, New York
Mt. Sinai Medical Center Recruiting
New York, New York, United States, 10029-0574
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Rosandra N Kaplan, M.D. National Cancer Institute (NCI)
Additional Information:
Publications:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01109394    
Other Study ID Numbers: 100086
10-C-0086
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: April 15, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Genomics
Proteomics
Tissue Repository
Omics
Cell Lines
Pediatric Cancer
Solid Tumor
Sarcoma
Kidney Cancer
Neuroblastoma
Additional relevant MeSH terms:
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Sarcoma
Neuroblastoma
Retinoblastoma
Kidney Neoplasms
Endocrine Gland Neoplasms
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases, Hereditary
Eye Diseases
Retinal Diseases
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Endocrine System Diseases