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Published results

G4K: Genomes for Kids

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:

  • Solid or liquid tumor (benign or malignant)

Why was this study done?

A genome is a person’s complete set of genes. When certain changes called mutations occur in certain Genomes for Kids, or G4K, is a research study for children with cancer. The main goal of the study was to see if doctors at St. Jude could use NGS to learn more about the genes in children’s cancer and also in their healthy cells. genes, cells may grow in ways that are not normal. This may cause a cancer to form. Scientists are using a new technology called next-generation genomic sequencing (NGS) to study many genes at the same time. NGS allows scientists to “read” each letter of the DNA code to find gene changes that may cause cancers to develop.

The study’s main goals

Genomes for Kids, or G4K, is a research study for children with cancer. The main goal of the study was to see if doctors at St. Jude could use NGS to learn more about the genes in children’s cancer and also in their healthy cells. We wanted to find out if these details could help doctors better understand why childhood cancers form and how to treat them.

Another goal of the study was to learn parents' views on NGS. We asked them:

  • For their thoughts on the benefits, risks, and expectations of genomic sequencing
  • About their decision to sign or not sign the NGS consent
  • How they wanted to receive the results of NGS
  • Questions to help us learn how well people understand the results of their genomic sequencing

When was this study done?

G4K opened in August 2015. It closed to new patients for a time, but reopened in July 2023.

What did the study consist of?

Changes that are present in every cell in the body are called "germline” changes. This study used NGS to find gene changes that were present only in cancer cells as well as germline changes that were present in cancer cells and healthy cells.

Because NGS in childhood cancer is new, the study aimed to find out if NGS could be used to provide helpful information for doctors and families. We used interviews, surveys, and a review of medical records to gather data. In total, 309 children enrolled in the study. They had cancer that was either newly diagnosed, was hard to treat, or had come back after treatment.

What did we learn from this study?

In the study, we learned that NGS could be effectively carried out. We also found that it provided important information for doctors, patients, and families.

In 86% of the patients, NGS identified gene changes that helped doctors better define the diagnosis, prognosis, and/or treatment. This helped show whether the cancer was passed down through families. In a small number of patients, cancer treatment changed due to NGS information.

Other findings include:

  • All parents who chose to complete surveys or interviews wanted to learn about the genomic results for treatable or preventable conditions.
  • Most wanted results even when there was no treatment or preventive options.
  • Parents were less interested in learning results for themselves than for their children.
  • Fewer parents were interested in learning results if their child died.
  • Most parents and adolescents felt that providers should share new or updated germline results.
  • Race or ethnicity played a role for families who declined to take part in the study.

What are the next research steps as a result of this study?

The results showed the importance of NGS in aiding in cancer diagnosis. It also showed the importance of high-quality genetic counseling before and after genomic testing. Clear communication is key when introducing genomic concepts. Sharing risk and benefit information through a 2-visit communication model helps improve families' understanding.

How does this study affect my child?

The G4K study set the stage for including NGS testing in cancer care for children at St. Jude. Now, all new St. Jude patients are offered a chance to have their tumor and/or healthy cells studied for gene changes so that the information can be used to improve their care.

Not all children may see a clinical benefit from genomic tests. But the information gained will help doctors learn more about childhood cancers in order to improve cancer care for children in the future.

For more information

Please ask your child’s St. Jude doctor if you have questions or concerns related to this study.

Publications generated from this study:

Genomes for Kids: The Scope of Pathogenic Mutations in Pediatric Cancer Revealed by Comprehensive DNA and RNA Sequencing. Newman S, Nakitandwe J, Kesserwan CA, Azzato EM, Wheeler DA, Rusch M, Shurtleff S, Hedges DJ, Hamilton KV, Foy SG, Edmonson MN, Thrasher A, Bahrami A, Orr BA, Klco JM, Gu J, Harrison LW, Wang L, Clay MR, Ouma A, Silkov A, Liu Y, Zhang Z, Liu Y, Brady SW, Zhou X, Chang TC, Pande M, Davis E, Becksfort J, Patel A, Wilkinson MR, Rahbarinia D, Kubal M, Maciaszek JL, Pastor V, Knight J, Gout AM, Wang J, Gu Z, Mullighan CG, McGee RB, Quinn EA, Nuccio R, Mostafavi R, Gerhardt EL, Taylor LM, Valdez JM, Hines-Dowell SJ, Pappo AS, Robinson G, Johnson LM, Pui CH, Ellison DW, Downing JR, Zhang J, Nichols KE. Cancer Discov. 2021 Dec 1;11(12):3008-3027. doi: 10.1158/2159-8290.CD-20-1631. PMID: 34301788 Free PMC article.

Knowledge Is Power: Benefits, Risks, Hopes, and Decision-Making Reported by Parents Consenting to Next-Generation Sequencing for Children and Adolescents with Cancer. Mandrell BN, Gattuso JS, Pritchard M, Caples M, Howard Sharp KM, Harrison L, Ouma AA, Valdez JM, Johnson LM, Nichols KE. Semin Oncol Nurs. 2021 Jun; 37(3):151167. doi: 10.1016/j.soncn.2021.151167. Epub 2021 Jun 12. PMID: 34127338 Review

Managing Pandora's Box: Familial Expectations around the Return of (Future) Germline Results. Johnson LM, Mandrell BN, Li C, Lu Z, Gattuso J, Harrison LW, Mori M, Ouma AA, Pritchard M, Sharp KMH, Nichols KE.AJOB Empir Bioeth. 2022 Jul-Sep;13(3):152-165. doi: 10.1080/23294515.2022.2063994. Epub 2022 Apr 26. PMID: 35471132

Factors Associated with Declining to Participate in a Pediatric Oncology Next Generation Sequencing Study. Howard Sharp KM, Jurbergs N, Ouma A, Harrison L, Gerhardt E, Taylor L, Hamilton K, McGee RB, Nuccio R, Quinn E, Hines-Dowell S, Kesserwan C, Sunkara A, Gattuso JS, Pritchard M, Mandrell B, Relling MV, Haidar CE, Kang G, Johnson LM, Nichols KE. JCO Precis Oncol. 2020; 4:202-211. doi: 10.1200/PO.19.00213. Epub 2020 Mar 24. PMID: 32395682

Speaking genomics to parents offered germline testing for cancer predisposition: Use of a 2-visit consent model. Johnson LM, Sykes AD, Lu Z, Valdez JM, Gattuso J, Gerhardt E, Hamilton KV, Harrison LW, Hines-Dowell SJ, Jurbergs N, McGee RB, Nuccio R, Ouma AA, Pritchard M, Quinn EA, Baker JN, Mandrell BN, Nichols KE. Cancer. 2019 Jul 15; 125(14):2455-2464. doi: 10.1002/cncr.32071. Epub 2019 Mar 22. PMID: 30901077

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.


Study goal:

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

For physicians and researchers

Patients accepted to St. Jude must be referred by a physician or other qualified medical professional. Learn how St. Jude can partner with you to care for your patient.


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