Genomic Profiling for Metastatic Solid Tumors

This study is looking at how using genomic profiling can help recommend treatments for people with cancer that has spread (metastatic cancer). Genomic profiling involves looking at the DNA of your tumor to find genetic changes. The goal is to see if this information can help doctors choose treatments that might work better for you. We want to find out if genomic profiling can identify changes that lead to treatment recommendations, and if treatments based on this profiling are more effective than standard care. You can join if you are an adult with metastatic, incurable cancer who has already tried at least one line of treatment, or if you have a cancer without a standard first-line treatment. The study will measure how often at least one treatable genetic change is found in your tumor.

Study design
This is an observational study with a planned enrollment of 100 participants. It is not a randomized trial.
What's involved
You would provide tissue samples at the start of the study and blood samples at the start and every 6-8 weeks during treatment. These samples will be analyzed for genetic changes.
Compensation
Not stated in the trial record.
Follow-up
After your active treatment is finished, you will have follow-up appointments at 4, 8, 12, 18, and 24 months.

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NCT02215928

Genomic Profiling in Recommending Treatment for Patients With Metastatic Solid Tumors

Recruiting
Not specifiedAges 18+Observational
Stanford University
~100 participants
Updated 2025-12-24 on ClinicalTrials.gov
What's tested:mutation analysiscytology specimen collection procedurelaboratory biomarker analysis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility, measured as the proportion of patients with at least one actionable alteration
Measured over Baseline
Unspecified Adult Solid Tumor, Protocol Specific

NCT02215928

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Stanford University

    Palo Alto, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • James M Ford, MD · PRINCIPAL_INVESTIGATOR · Stanford University

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Eligibility criteria

Inclusion

Understand and provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization prior to initiation of any study-specific procedures
Have a diagnosis of metastatic, incurable cancer and have progressed on at least one line of systemic therapy OR a cancer with no standard 1st-line systemic therapy shown to prolong survival (or where a clinical trial recommended as the 1st-line option)
Measurable disease (RECIST 1.1)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
In the opinion of the investigator, be medically suitable for and willing to undergo a biopsy or surgical procedure to obtain tissue as a part of routine care for their malignancy OR have adequate archival tissue from a previous biopsy available for profiling
Female patients of childbearing potential must have a negative pregnancy test and agree to use at least one form of contraception during the study and for at least one month after treatment discontinuation; for the purposes of this study, child-bearing potential is defined as: all female patients that were not in post-menopause for at least one year or are surgically sterile
Male patients must use a form of barrier contraception approved by the investigator/treating physician during the study and for at least one month after treatment discontinuation

Exclusion

Have lesions that are not accessible to biopsy or not planned for biopsy as part of routine care OR if archival tissue will be used for profiling, an insufficient amount is available
Have diagnosis of a hematologic malignancy
Have symptomatic central nervous system (CNS) metastasis; patients with a history of CNS metastases who have been treated with whole brain irradiation must be stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for \>= 2 weeks prior to enrollment
Have uncontrolled concurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
Have known human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) infection
Are pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception
  • Feasibility, measured as the proportion of patients with at least one actionable alterationBaseline

    An actionable alteration is defined as availability of targeted therapy, scored as: A) an FDA-approved drug, B) an FDA-approved drug in another tumor type, or C) a drug that is not yet approved but has a clinical trial open. The percentage of patients in the "profile" arm with successful profiling will be calculated and further characterized by availability category.