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Understanding Genetic Changes in Pediatric Cancer

This observational study at St. Jude Children's Research Hospital is looking at the genetic makeup of children with cancer. Researchers are using advanced genetic testing, called next generation sequencing (NGS), to understand the genetic changes in both tumor cells and normal cells. The goal is to find out how common certain genetic changes are in children with cancer, and how these changes might relate to their illness, treatment, and outcomes. This study is open to St. Jude patients with solid, liquid, or central nervous system tumors, as long as enough tissue is available for testing. The study aims to enroll 2500 participants.

Study design
This is an observational study, meaning participants are not given a specific treatment but are studied over time. It plans to enroll 2500 participants.
What's involved
You would have an introduction visit with a genetic counselor and clinician, followed by an informed consent visit. There will be conversations to return your genetic results, and two follow-up visits after that.
Compensation
Not stated in the trial record.
Follow-up
You will have follow-up visits for about 8 weeks and 28 weeks after your results are returned.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02530658

Next Generation Sequencing of Normal Tissues Prospectively in Pediatric Oncology Patients

Recruiting
Not specifiedAll AgesObservational
St. Jude Children's Research Hospital
~2,500 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:Study Introduction VisitInformed Consent VisitInformed Consent Follow-Up VisitReturn of Results ConversationReturn of Results Follow-Up VisitsBlood Sample

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall success rate
Measured over Approximately 3 months after study enrollment
+1 more outcome measured

Conditions

Solid, Liquid, Central Nervous System Tumors

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Central Nervous System NeoplasmGenetic Predisposition to DiseaseHematologic NeoplasmSolid Neoplasm

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Kim E. Nichols, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Kim E. Nichols, MD
[email protected]
888-226-4343
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

St. Jude patients prospectively identified at the time of study activation with a diagnosed solid or liquid tumor (benign or malignant).
Adequate tissue must be available (e.g. sufficient germline and/or tumor tissue, from which \>1 µg DNA and \>0.1 µg RNA must be isolated). Patients who have no tumor tissue available may enroll using only germline sample.

Exclusion

Past history of hematopoietic stem cell transplantation (or other condition that would result in hematopoietic cell DNA failing to match host tissue DNA).
Tumor or germline tissue not meeting the criteria listed above.
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Participants who are unable to read, write or converse fluently in English or Spanish will be excluded from Prespecified Objectives 3 and 4.

What this trial measures

  • Overall success rateApproximately 3 months after study enrollment

    Success is defined by the combined successes of (1) quality interpretable genomic data are generated from sequencing tumor and germline tissues, and (2) communicating genomic test results to the primary SJCRH oncologist and the patient and his/her parents. The Binomial proportion of successful performance will be estimated by the sample proportion and the 99% confidence interval based on the normal approximation. Sample size is 400.

  • Number and type of somatic genetic variants and germline genetic variantsApproximately 3-4 months after the germline sample is obtained

    WGS, WES and RNA sequence data will be used to identify and characterize somatic genetic variants of pathological significance and germline genetic variants associated with increased cancer risk. Descriptive statistics, such as counts and proportions of variants associated with increased cancer risk will be computed within each patient and in each disease type.