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

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Brief Title

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

Official Title

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

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.
    

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.

      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 or normal well visit.

        -  Biological relatives of a subject with a pediatric tumor or malignancy 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 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, 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

             -  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.

             -  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 100-150 patients per year.
    


Study Type

Observational


Primary Outcome

tissue analysis


Condition

Sarcoma


Study Arms / Comparison Groups

 1/Cohort 1
Description:  Adult or Pediatric subjects, with any malignancy, pre-malignancy, suspected malignancy, family history of malignancy, or without malignancy undergoing surgery or well visit.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

6035

Start Date

April 21, 2010



Eligibility 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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Rosandra N Kaplan, M.D., (240) 760-6189, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01109394

Organization ID

100086

Secondary IDs

10-C-0086

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

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


Verification Date

September 30, 2021