NCT02688517

Targeted Genomic Analysis of Blood and Tissue Samples From Patients With Cancer

Targeted Genomic Analysis of Human Cancers

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,100 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

This research trial studies the use of targeted genomic analysis of blood and tissue samples from patients with cancer. Genomic sequencing is a laboratory method that is used to determine the entire genetic makeup of a specific organism or cell type. Genomic sequencing can be used to find changes in areas of the genome that may be important in the development of cancer. It may also help doctors improve ways to diagnose and treat patients with rare cancers with poor prognosis or lack of effective therapy.

Detailed description

PRIMARY OBJECTIVES: I. To obtain blood and tumor tissue for next-generation sequencing and determine the frequency of finding genomic alterations for which there are clinically available (commercially or research based) targeted therapies. Treating clinicians will be provided with relevant validated mutation data for treatment or referral of the patient to pertinent studies. II. To collect clinical outcomes of patients with actionable mutations for which sequencing has been performed. III. To obtain tumor genome data for data storage and future computational analysis and correlation with clinical data. IV. To obtain tumor tissue for development of future in vitro and in vivo cancer models. OUTLINE: Previously collected tissue samples are analyzed for the presence of mutations via next generation sequencing. Patients may also undergo collection of blood samples for analysis of circulating cell-free deoxyribonucleic acid (DNA) and circulating tumor cells. After completion of study, patients are followed up every 3 months for 2 years and then every 6 months for 15 years.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	Cytology Specimen Collection Procedure	Undergo collection of blood samples
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2013-02-01
• Primary completion: 2030-05-01
• Completion: 2030-05-01
• First posted: 2016-02-23
• Last updated: 2026-04-17

Locations

11 sites across 1 country: United States