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

Last updated: April 15, 2025
Sponsor: National Cancer Institute (NCI)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Urologic Cancer

Renal Cancer

Urothelial Tract Cancer

Treatment

N/A

Clinical Study ID

NCT01109394
100086
10-C-0086
  • Ages > 4
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

  • SUBJECT INCLUSION CRITERIA:

Pediatric or adult subjects with one of the following:

  • Diagnosis of any tumor, malignancy, pre-malignant disorder, or suspectedpremalignant familial syndromes, regardless, of patient age;

  • Biological relatives of any patient with a tumor, malignancy, pre-malignantdisorder, or suspected familial pre-malignant syndrome, regardless of patient age orthe diagnosis of an adult malignancy or pre-malignant disorder;

  • Healthy Volunteer without history of malignancy nor a family member currently beingtreated for cancer who are undergoing surgery, treatment or during well visits;

  • Biospecimens can be collected with minimal additional risk to the subject duringsampling or procedures required for routine patient care.

  • Human samples, specimens and data collected on IRB approved protocols that are nowclosed

  • Ability of subject, Legally Authorized Representative (LAR), or parent/legalguardian of children less than or equal to 18 to understand and be willing to signan IRB-approved informed consent document that permits the use of the tumor andother 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 treatedfor, 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

EXCLUSION CRITERIA:

None

Study Design

Total Participants: 6035
Study Start date:
April 21, 2010
Estimated Completion Date:

Study 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 tumor or malignancy (pediatric or adult) or with suspected familial cancer syndrome. Patients enrolled in an approved companion protocol

  • 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 extracted from a section of tumor and normal samples; the remainder will be stored.

    • Germ line DNA and RNA extracted from lymphocytes or other normal uninvolved tissue

    • Germ line DNA will be extracted from lymphocytes or other normal uninvolved tissue of 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 of 100-150 patients per year.

Connect with a study center

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Completed

  • Childrens National Medical Center

    Washington, District of Columbia
    United States

    Site Not Available

  • Children's Hospital of Orange County

    Orange, Florida 92613
    United States

    Site Not Available

  • Children's Hospital of Orange County (CHOC Children's)

    Orange, Florida 92613
    United States

    Site Not Available

  • National Institutes of Health Clinical Center

    Bethesda, Maryland 20892
    United States

    Active - Recruiting

  • Tisch Cancer Institute, Mount Sinai Medical Center

    New York, New York 10029-0574
    United States

    Site Not Available

  • Tisch Cancer Institute, Mt. Sinai Medical Center

    New York, New York 10029-0574
    United States

    Site Not Available

  • Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Carolinas Medical Center/Levine Children's Hospital

    Charlotte, North Carolina 28203
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.