NCT02530658 Next Generation Sequencing of Normal Tissues Prospectively in Pediatric Oncology Patients
| NCT ID | NCT02530658 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Solid, Liquid, Central Nervous System Tumors |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2015-08-28 |
| Primary Completion | 2045-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2015-08-28 with a primary completion date of 2045-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The development of next generation sequencing (NGS) techniques, including whole genome (WGS), exome (WES) and RNA sequencing has revolutionized the ability of investigators to query the molecular mechanisms underlying tumor formation. Through the Pediatric Cancer Genome Project (PCGP), investigators at St. Jude Children's Research Hospital (SJCRH) have successfully used NGS approaches to evaluate more than 1,000 pediatric cancers ranging from hematologic malignancies to central nervous system (CNS) and non-CNS solid tumors. From these and related studies, it has become clear that 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. Collectively, these studies suggest that by characterizing the genomic make-up of individual tumors, investigators will be able to develop personalized and potentially more effective cancer treatments and/or preventive measures. This protocol was initially enacted to usher NGS approaches into routine clinical care. During the initial phase of the G4K protocol, 310 participants were recruited and enrolled onto the study. Tumor and/or germline sequencing was completed on all 310 patients, with 253 somatic reports generated (representing 96% of the 263 participants for whom tumor tissue was available and analyzed) and 301 germline reports generated (100% of the 301 participants who agreed to the receipt of germline results). Analyses of the study data are ongoing with plans to prepare initial manuscripts within the next several months. Due to the successful initial execution of the G4K protocol, clinical genomic sequencing of tumor and germline samples is now offered as part of standard clinical care for pediatric oncology patients at St. Jude. The G4K protocol has now been revised. With the revision, the study team will record, store and analyze germline and tumor genomic information. Through the collection of these data, we will examine how germline mutations in 150 cancer predisposition genes influence clinical presentation, tumor histology, tumor genomic findings, response to therapy and long-term outcomes. The overall goals of this research are to further define the prevalence, spectrum and heritability of germline variants in these genes and to decipher how germline mutations influence the phenotypes of an expanding array of cancer predisposition syndromes. These studies allow us to provide more accurate genetic counseling and management strategies to future children harboring mutations in these genes. This remains a non-therapeutic study. Investigators anticipate a sample size of approximately 2500 patients who will be recruited over the next 7 years.
Eligibility 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.
Contact & Investigator
Kim E. Nichols, MD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT02530658 clinical trial?
This trial is open to participants of all sexes, studying Solid, Liquid, Central Nervous System Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02530658 currently recruiting?
Yes, NCT02530658 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT02530658 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT02530658 clinical trial?
NCT02530658 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Kim E. Nichols, MD at St. Jude Children's Research Hospital. The trial plans to enroll 2,500 participants.