G4K: Genomes for Kids

Non-therapeutic study examining the feasibility, acceptance and impact of clinical WGS, WES and RNA sequencing in a pediatric oncology setting

Category:

Genetics & Genomics

Diseases Treated:

Solid and liquid tumors

Eligibility Overview:

This is a non-therapeutic clinical trial that is open to new St. Jude patients. The patient has:

  • cancerous or non-cancerous tumor that has been newly diagnosed
  • recurred after previous treatment
  • not responded to previous treatment (refractory disease)

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.

Description

Genomes for Kids (G4K) is a St. Jude clinical trial for children and teens who have been diagnosed with a solid or liquid tumor. The main purpose of G4K is to use a new type of test known as genomic sequencing to understand the similarities and differences between tumor cells and healthy cells in children. By doing this study, researchers hope to learn more about childhood tumors, how genomic sequencing might help predict tumor response to treatment, and the best ways to share genomic sequencing results with families.

  1. Primary Objectives

    • To perform clinical next generation WGS, WES, and RNA sequencing on St. Jude pediatric oncology patients prospectively over a 12-month period.
    • To use WGS, WES, and RNA sequence data to identify and characterize somatic genetic variants of pathological significance and germline genetic variants associated with increased cancer risk.

    Exploratory Objectives

    • To generate and analyze data describing the informed consent process and patient/parent perceptions of genomic investigations and research.
    • 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 WES and RNA sequencing on derivatives from formalin-fixed, paraffin-embedded (FFPE) tumor samples alongside the analysis of matched frozen tumor and germline samples.

    Trial Outline

    G4K is a non-therapeutic research study examining the feasibility, acceptance and impact of clinical WGS, WES and RNA sequencing in a pediatric oncology setting. This study will be offered to patients with newly diagnosed, relapsed or refractory tumors who are prospectively accepted to undergo treatment at St. Jude over a-12-month period following study activation.

    A research nurse will identify potential participants and explain the G4K study. Interested eligible patients and their parents will meet with a member of the study team, and a clinical intake and informed consent process will take place. For patients who give consent, a tumor and/or normal tissue sample will be obtained and used for WGS, WES and RNA sequence analysis. Once the results of these analyses are available, they will be disclosed to physicians, patients and parents. Mixed measures approaches will be used to assess understanding, acceptance and impact of genomic results on patients and parents.

    Interventions

    • Patient enrollment
    • Patient consent
    • Sample collection (tumor and/or normal tissue)

    Eligibility Criteria

    Inclusion Criteria:

    • St. Jude patients prospectively identified at the time of study activation with at least one of the following:
      • 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)
      • Recurrent or refractory disease, where biopsy or resection is being performed to establish the diagnosis and/or palliate symptoms
    • St. Jude patients identified prior to study activation who have recurrent or refractory disease, where biopsy or resection is being performed to establish the diagnosis and/or palliate symptoms
    • Adequate tissue must be available (eg., sufficient germline and/or tumor tissue, from which >1 µg DNA and >0.1 µg RNA must be isolated
      • Patients with retinoblastoma, diffuse intrinsic pontine glioma or optic pathway tumors who have no tumor tissue available may enroll using only a germline sample

    Exclusion Criteria:

    • History of hematopoietic stem cell transplantation or other condition that would result in hematopoietic cell DNA failing to match host tissue DNA
  2. About Genomes for Kids

    Genomes for Kids is a research study being led by St. Jude. It is for children and teens who have been diagnosed with a solid or a liquid tumor, also known as leukemia or lymphoma. In this study, the researchers will use genomic sequencing to learn about your child’s tumor and his or her healthy cells. Genomic sequencing is a test that will help researchers learn more about the similarities and differences between tumors and healthy cells in children. Most children with tumors do not yet have this kind of test as part of their regular care. By doing this study, St. Jude hopes to learn more about the reasons childhood tumors form, whether this test can help doctors predict how tumors will respond to treatment and the best ways to share the results of genomic sequencing with families.

    To learn more about the study, genomic sequencing, DNA and more, read Genomes for Kids Research Study.

  3. G4K Quick View
    Sponsor St. Jude Children’s Research Hospital 
    Clinicaltrials.gov identifier NCT02530658
    Trial start date 08/21/15
    Estimated enrollment 400
    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

Contact

Principal Investigator

Kim E. Nichols, MD

Co-Principal Investigators

James R. Downing, MD
Jinghui Zhang, PhD

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.