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 October 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01109394
First received: April 22, 2010
Last updated: April 8, 2014
Last verified: October 2013

April 22, 2010
April 8, 2014
April 2010
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Complete list of historical versions of study NCT01109394 on ClinicalTrials.gov Archive Site
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Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies
Comprehensive Omics Analysis of Pediatric Solid Tumors and Establishment of a Repository for Related Biological Studies

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.

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 consenting patients enrolled at the Pediatric Oncology Branch, Children s National Medical Center (CNMC), Carolinas Medical Center/Levine Children s Hospital, and collaborative institutions.
  • Establish a sample acquisition protocol for the collection and banking of pediatric solid tumors and paired normal tissue to support research conducted by the collaborative studies at the NIH, Children s National Medical Center (CNMC), Carolinas Medical Center/Levine Children s Hospital, and other extramural institutions.
  • Investigate the growth factor and cellular profile of different pediatric and adult malignancies and correlate this with disease course by measuring circulating levels of growth factors, microvesicles and bone marrow-derived cells including hematopoietic progenitor cells (HPCs), endothelial progenitor cells (EPCs), mesenchymal progenitor cells (MPCs) and matrix metalloproteases (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.
  • Identify caregiver attitudes toward the use of next generation sequencing (NGS) at the NIH for diagnosing and managing pediatric cancer and the return of NGS genetic test results and

incidental findings to caregivers.

- 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 NIH patients, caregivers, and the family system.

Eligibility:

  • 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 tumor or malignancy or with suspected familial cancer syndrome.
  • Biological relatives of a subject with an adult tumor or malignancy or with suspected familial cancer syndrome.
  • Blood and/or tissue specimens that have been previously collected and are available for study or that can be collected with minimal additional risk to the subject during sampling 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.
  • Specimens will be collected and stored at the Advanced Technology Center, Gaithersburg, MD
  • Linked clinical and demographic data will be stored in the HIPAA compliant, secure web-based database (Labmatrix).
  • Testing activities may include:

    • DNA, RNA and protein will be extracted from a section of tumor samples, the remainder will be stored.
    • Germ line DNA and RNA will be extracted from lymphocytes or other normal uninvolved tissue
    • Germ line DNA will be extracted from lymphocytes or other normal uninvolved tissue of the biological relatives of the subject.
    • Xenografts and cell lines will be established from tumor samples
    • Blood and/or Bone Marrow will be sent to Coriell Institute for Medical Research for the establishment of EBV transformed cell lines.
    • Tumor samples sent to Molecular Response for the establishment of Xenografts and single cell suspension of tumor for drug testing
    • Omics (Genomics and Proteomic) studies will be performed
    • Growth factor and cellular profile investigations of bone marrow-derived cell populations to include quantification of hematopietic 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.
  • Establishing 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 50-100 patients per year per center equaling approximately 150 patients

enrolled per year. Total protocol accrual goal 2,000 patients and 4000 biologic relatives, and up to 35 caregivers, for a total of 6035 participants.

Observational
Time Perspective: Retrospective
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  • Sarcoma
  • Endocrine Tumors
  • Neuroblastoma
  • Retinoblastoma
  • Renal Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6035
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  • 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

Both
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Yes
Contact: Donna M Bernstein, R.N. (301) 435-7804 db302w@nih.gov
Contact: Javed Khan, M.D. (301) 435-2937 khanjav@mail.nih.gov
United States
 
NCT01109394
100086, 10-C-0086
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National Cancer Institute (NCI)
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Principal Investigator: Javed Khan, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP