NCT02215928

Genomic Profiling in Recommending Treatment for Patients With Metastatic Solid Tumors

Tumor Genomic Profiling: A Personalized Medicine Approach

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research trial studies using genomic profiling to recommend anticancer treatment to patients with cancer that has spread beyond the original site of the tumor (metastatic cancer). Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect genetic changes or abnormalities. This information can then be used to recommend treatments that may be more likely to result in a beneficial response. It is not yet known whether genomic profiling will detect abnormalities that can be used to make treatment recommendations and whether treatment based on genomic profiling is more effective than standard treatment.

Detailed description

PRIMARY OBJECTIVES: I. Assess the feasibility of integrating tumor genomic profiling in the adult oncology clinic at the Stanford Cancer Institute. SECONDARY OBJECTIVES: I. Determine the percentage of tumors that harbor "actionable" genomic changes. II. Explore effects of individual molecular profiling including the percent of time that profiling changes the treatment. III. Determine the number of cases in which a genomically identified targeted therapy is available. IV. Determine the clinical benefit of genomic based therapy, as defined by: response rate (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 response criteria); the percent of patients with non-progression at 4 months, and overall survival, in patients whose therapy is selected based on profiling. V. Determine if circulating free tumor DNA (ctDNA) in the blood stream (liquid biopsy) yields similar genomic results as the metastatic tumor analysis. VI. Determine if ctDNA analysis during treatment correlates with RECIST 1.1 criteria in predicting response. OUTLINE: Tissue samples are collected at baseline and blood for liquid biopsy is collected at baseline and every 6-8 weeks during active treatment. Tissue samples are analyzed via sequencing for tumor genomic profiling. After completion of active treatment, participants are followed up at 4, 8, 12, 18, and 24 months.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
GENETIC	mutation analysis	Correlative studies
OTHER	cytology specimen collection procedure	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-07-28
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2014-08-13
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States