G4K: Genomes for Kids

Next Generation Sequencing of Tumor and Normal Tissues Prospectively in Pediatric Oncology Patients

Categories:

Leukemia / Lymphoma

Genetics & Genomics

Solid Tumor

Diseases Treated:

Non-therapeutic

Eligibility Overview:

This is a non-therapeutic clinical trial that is open to new St. Jude patients. The protocol is also open to current St. Jude patients with recurrent or refractory disease, where biopsy or resection is being performed to establish the diagnosis and/or palliate symptoms.

  • Solid tumor or liquid tumor (cancerous or non-cancerous)
  1. Brief Summary

    The development of next generation sequencing (NGS) techniques, including whole genome sequencing (WGS), whole exome sequencing (WES) and RNA sequencing, has revolutionized our ability to query the molecular mechanisms underlying tumor formation. Through the Pediatric Cancer Genome Project (PCGP), we have successfully used NGS approaches to evaluate more than 1,000 pediatric cancers. These and other studies have shown genomic approaches can accurately classify tumors into distinct pathologic and prognostic subtypes and detect alterations in cellular pathways that may serve as novel therapeutic targets. As a result of our research, we routinely offer clinical genomic testing of tumor and germline to patients at St. Jude.

    In this protocol, we will offer all oncology patients the opportunity to undergo germline genetic testing of 150 cancer predisposition genes and explore how identified mutations in these genes influence clinical presentation and outcome. We will also assess patient and family attitudes about genetic testing.

    Primary Objectives

    • To use clinical genomic sequencing to define the prevalence and spectrum of germline mutations in cancer predisposition genes in children with cancer
    • To correlate germline genomic information with clinical presentation, tumor genomic findings, treatment response, and outcome

    Exploratory Objectives

    • To generate and analyze data describing the patient/parent perceptions of genomic investigations and research at various time points throughout the study
    • To generate and analyze data surrounding the return of genomic sequencing results, examine patient/parent understanding of these results and assess the impact of results on patients and families
    • To determine the feasibility and reliability of performing whole exome sequencing WES and RNA sequencing on derivatives from formalin-fixed, paraffin-embedded (FFPE) tumor samples alongside the analysis of matched frozen tumor and germline samples

    Eligibility Criteria

    Inclusion criteria include:

    St. Jude patients with:

    • Newly diagnosed solid or liquid tumor (benign or malignant)
    • Relapsed solid or liquid tumor (benign or malignant)
    • Refractory solid or liquid tumor (benign or malignant)

    Patients who have no tumor tissue may enroll using only a germline sample.

    Exclusion Criteria include:

    • History of hematopoietic stem cell transplantation or other condition that would result in hematopoietic cell DNA failing to match host tissue DNA
    • Does not wish to learn his or her germline sequencing results of the 150-gene panel

    Study Sites

    St. Jude Children’s Research Hospital, Memphis, Tennessee

  2. About this study

    Genomes for Kids (G4K) is a research study for children and teens who have been diagnosed with a solid or a liquid tumor.

    A genome is a person’s complete set of genes. Researchers are using a new technology called “genomic sequencing” to study many genes at the same time. This process of genetic testing looks for changes in genes, also called genetic mutations. These changes may affect how diseases, such as tumors, develop.

    In this study, the researchers will use genomic sequencing to learn about your child’s healthy cells.

    Purpose of this clinical trial

    The main goal of this study is to learn more about the reasons childhood tumors form and how to treat them better.

    Eligibility overview

    St. Jude patients with:

    • Newly diagnosed solid or liquid tumor (benign or malignant)
    • Relapsed solid or liquid tumor (benign or malignant)
    • Refractory solid or liquid tumor (benign or malignant)
  3. G4K Quick View
    Sponsor St. Jude Children’s Research Hospital 
    Clinicaltrials.gov identifier NCT02530658
    Trial start date August 2015
    Estimated enrollment 5000
    Study type Non-therapeutic, prospective
    Conditions

    Solid and liquid tumors

    Ages Any
    Principal investigator Kim E. Nichols, MD
    Study site St. Jude Children’s Research Hospital
    For a consultation or to discuss G4K St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Kim E. Nichols, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.