Genomic analysis of normal tissues in children with cancer
Genomes for Kids (G4K)
This study is trying to find genetic changes in healthy tissues of children with cancer to see how these changes might affect their treatment and understanding of cancer risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT02530658 on ClinicalTrials.gov |
What this trial studies
This study aims to utilize next generation sequencing techniques to identify germline mutations in cancer predisposition genes among pediatric oncology patients. By analyzing normal tissue samples alongside tumor samples, the researchers will correlate genetic findings with clinical outcomes and treatment responses. The study also seeks to understand patient and parent perceptions of genomic testing and the impact of these results on their understanding of cancer risk and treatment options. The ultimate goal is to enhance personalized cancer treatment and prevention strategies for children.
Who should consider this trial
Good fit: Ideal candidates include children diagnosed with solid or liquid tumors who have adequate tissue samples available for genomic analysis.
Not a fit: Patients who have undergone hematopoietic stem cell transplantation or lack sufficient tumor or germline tissue will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective cancer treatments for pediatric patients.
How similar studies have performed: Other studies utilizing genomic sequencing in pediatric oncology have shown promising results, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Kim E. Nichols, MD — St. Jude Children's Research Hospital
- Study coordinator: Kim E. Nichols, MD
- Email: referralinfo@stjude.org
- Phone: 888-226-4343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.