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NCT02530658 · ClinicalTrials.gov registry record
Next Generation Sequencing of Normal Tissues Prospectively in Pediatric Oncology Patients
A clinical trial of Solid, Liquid, Central Nervous System Tumors, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- 2,500
- Enrollment target
- 1
- Study location
NCT02530658 is a study of Solid, Liquid, Central Nervous System Tumors that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 2,500 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02530658, a study of Solid, Liquid, Central Nervous System Tumors, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- 2,500 participants
- Enrollment target
- 1
- Study location
Study 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 collectio
Conditions Studied
Interventions
- OTHER Study Introduction Visit
- OTHER Informed Consent Visit
- OTHER Informed Consent Follow-Up Visit
- OTHER Return of Results Conversation
- OTHER Return of Results Follow-Up Visits
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,500 participants |
| Start Date | 2015-08-28 |
| Est. Completion | 2038-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02530658
The ClinicalTrials.gov registry entry for NCT02530658 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 2,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Solid, Liquid, Central Nervous System Tumors appearing as the primary indexed condition, and to 5 interventions - of which Study Introduction Visit is the first listed.
NCT02530658 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT02530658 about?
NCT02530658 is a clinical study titled "Next Generation Sequencing of Normal Tissues Prospectively in Pediatric Oncology Patients". 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...
What is the current status of trial NCT02530658?
This trial is currently recruiting. The enrollment target is 2,500 participants. The study started on 2015-08-28. Estimated completion is 2038-12-31.
What conditions does trial NCT02530658 study?
This clinical trial studies the following conditions: Solid, Liquid, Central Nervous System Tumors.
What interventions are being tested in trial NCT02530658?
The interventions under investigation include: Study Introduction Visit (OTHER), Informed Consent Visit (OTHER), Informed Consent Follow-Up Visit (OTHER), Return of Results Conversation (OTHER), Return of Results Follow-Up Visits (OTHER).
Who is sponsoring clinical trial NCT02530658?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02530658 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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