Using genomic profiling to recommend cancer treatment for patients with metastatic tumors
Tumor Genomic Profiling: A Personalized Medicine Approach
This study tests if analyzing the DNA of metastatic tumors can help doctors recommend better treatments for cancer patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT02215928 on ClinicalTrials.gov |
What this trial studies
This research focuses on the use of genomic profiling to guide treatment recommendations for patients with metastatic solid tumors. By analyzing the DNA of tumors, the study aims to identify genetic changes that could inform more effective treatment options. The primary objective is to assess the feasibility of integrating genomic profiling into clinical practice at the Stanford Cancer Institute, while secondary objectives include evaluating the prevalence of actionable genomic changes and the clinical benefits of therapies based on genomic data. Participants will undergo tissue and blood sample collection for analysis, with follow-up assessments conducted over two years.
Who should consider this trial
Good fit: Ideal candidates are adults with metastatic, incurable cancer who have progressed on at least one line of systemic therapy or have no standard first-line treatment options.
Not a fit: Patients with early-stage cancer or those who have not yet undergone systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective cancer treatments for patients with metastatic disease.
How similar studies have performed: Other studies have shown promise in using genomic profiling for treatment recommendations, indicating a growing interest and potential in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Palo Alto, California
- Stanford University — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: James M Ford, MD — Stanford University
- Study coordinator: Rozelle Laquindanum
- Email: rlaquind@stanford.edu
- Phone: (650) 724-9948
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.