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

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ClinicalTrials.gov Identifier: NCT01109394
Recruitment Status : Recruiting
First Posted : April 23, 2010
Last Update Posted : June 21, 2018
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 Detailed Description

Study Type : Observational
Estimated Enrollment : 6035 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies
Study Start Date : April 19, 2010





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


Secondary Outcome Measures :
  1. Tissue repository [ Time Frame: 1 year ]
    Create a tissue repository designed to allow blood, serum, plasma, urine, stool, buccal swabs, bone marrow, CSF, malignant ascites and malignant effusions, normal tissue and tumor sample collection and storage for use in the study of patients with or without a malignancy. Human samples, specimens and data collected on IRB approved protocols that are now terminated may be transferred for continued analysis and new research without additional risk, on this study.

  2. Growth factors & cellular profile analysis [ Time Frame: 1 year ]
    Investigate the growth factor and cellular profile of different pediatric and adult malignancies and correlate this with disease course by measuring circulating levels of circulating tumor cells, growth factors, microvesicles, cell free DNA and bone marrow- derived cells including immune cells, HPCs, EPCs, MPCs and MMPs in the blood and urine of pediatric and adult patients without malignancy, as well as patients with pediatric and adult malignancies, and determining if these levels predict development of metastasis, or change during treatment, such as when undergoing surgery, chemotherapy and other treatments such as immunotherapy.

  3. Establish cell lines & Xenografts (tumor and normal lymphocytes) [ Time Frame: 1 year ]
    Establish cell lines and Xenografts from tumor samples and cell lines from normal cells.

  4. Oversight committee [ Time Frame: 1 year ]
    Create an oversight committee to oversee a variety of laboratory investigations designed to support NIH translational studies, to apply new methodologies in the investigation of cellular, molecular, genetic, and genomic biology, to probe for new therapeutic targets, and to develop new treatment approaches.

  5. Identify caregiver attitudes regarding NGS [ Time Frame: 1 year ]
    Identify caregiver attitudes toward the use of next generation sequencing (NGS) for diagnosing and managing pediatric cancer and the return of NGS genetic test results and incidental findings to caregivers.

  6. QOL vs impact of NGS genetic test results [ Time Frame: 1 year ]
    Evaluate the anticipated short- and long-term impact of returning NGS genetic test results for cancer and incidental findings on quality of life and related bioethical outcomes among patients, caregivers and the family system.



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Ages Eligible for Study:   up to 99 Years   (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. 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.
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
  • Subjects greater than or equal to 18 or parent/guardian or Legally Authorized Representative (LAR) of children less than or equal to 18 must have 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:


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
Contact: Donna M Bernstein, R.N. (240) 760-6189 db302w@nih.gov
Contact: Rosandra N Kaplan, M.D. (301) 496-1735 kaplanrn@mail.nih.gov

Locations
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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Rosandra N Kaplan, M.D. National Cancer Institute (NCI)

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01109394     History of Changes
Other Study ID Numbers: 100086
10-C-0086
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: May 24, 2018

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:
Retinoblastoma
Sarcoma
Neuroblastoma
Kidney Neoplasms
Carcinoma, Renal Cell
Endocrine Gland Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
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
Retinal Diseases
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Endocrine System Diseases