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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01109394
First received: April 22, 2010
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

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
Sarcoma
Endocrine Tumors
Neuroblastoma
Retinoblastoma
Renal Cancer

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Tissue analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tissue repository [ Time Frame: 1 year ]
  • Growth factors & amp; cellular profile analysis [ Time Frame: 1 year ]
  • Establish cell lines & amp; Xenografts (tumor and normal lymphocytes) [ Time Frame: 1 year ]
  • Oversight committee [ Time Frame: 1 year ]
  • Identify caregiver attitudes regarding NGS [ Time Frame: 1 year ]
  • QOL vs impact of NGS genetic test results [ Time Frame: 1 year ]

Estimated Enrollment: 6035
Study Start Date: April 2010
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Pediatric or adult patients with one of the following:

    • Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspected premalignant familial syndromes, regardless, of patient age.; OR
    • Biological relatives of any patients with pediatric 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;

OR

  • Individuals without history of malignancy who are undergoing surgery, treatment or during well visits; OR
  • Tissue (including tumor, normal, blood, serum, plasma or urine) that has been previously collected and is available for study or that can be collected with minimal additional risk to the subject during sampling or procedures required for routine patient care.

    • Individual may be undergoing treatment for malignancy or other health problem.
    • Informed consent or IRB waiver of the requirement for informed consent for specific types of tissue as detailed.

EXCLUSION CRITERIA:

None

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109394

Contacts
Contact: Donna M Bernstein, R.N. (301) 435-7804 db302w@nih.gov
Contact: Rosandra N Kaplan, M.D. (301) 496-1735 kaplanrn@mail.nih.gov

Locations
United States, District of Columbia
Childrens National Medical Center Recruiting
Washington, District of Columbia, United States
United States, Florida
Children's Hospital of Orange County Recruiting
Orange, Florida, United States, 92613
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      
Sponsors and Collaborators
Investigators
Principal Investigator: Rosandra N Kaplan, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01109394     History of Changes
Other Study ID Numbers: 100086, 10-C-0086
Study First Received: April 22, 2010
Last Updated: September 26, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Genomics
Proteomics
Tissue Repository
Omics
Cell Lines
Pediatric Cancer
Solid Tumor
Sarcoma
Kidney Cancer
Neuroblastoma

Additional relevant MeSH terms:
Retinoblastoma
Carcinoma, Renal Cell
Endocrine Gland Neoplasms
Kidney Neoplasms
Neoplasms
Neuroblastoma
Sarcoma
Adenocarcinoma
Carcinoma
Endocrine System Diseases
Eye Diseases
Eye Neoplasms
Kidney Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Retinal Diseases
Retinal Neoplasms
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014