This pilot research trial studies molecular profiling in tissue samples from patients with cancer who got better with treatment that didn't work for most other patients with the same disease. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to how well patients respond to treatment.
PRIMARY OBJECTIVES: I. To identify molecular indicators in malignant tissues from patients who were exceptional responders on clinical trials or standard systemic treatments using whole exome and/or targeted deep sequencing, as well as potentially other sequencing and other molecular characterization methods (if adequate tissue exists). II. To explore associations between the identified molecular indicators and the putative mechanism of action of the treatment received by the patient. III. To test the feasibility of identifying "exceptional responders", obtaining the relevant tumor and normal tissue and clinical data, and performing whole exome and/or targeted deep sequencing on these samples. OUTLINE: Previously collected tissue samples are analyzed via whole exome sequencing and/or targeted next generation sequencing (NGS) assay deep sequencing. Cases for which sufficient nucleic acid amounts are available will undergo additional analyses including whole genome sequencing, messenger ribonucleic acid (RNA) (mRNA)-sequencing, micro (miRNA) sequencing, promoter methylation analysis, and single nucleotide polymorphism (SNP) analysis.
Study Type
OBSERVATIONAL
Enrollment
170
Undergo sequencing and SNP analysis
Molecular features in tissue samples from patients who were exceptional responders
The molecular features of the tumors in the patients will be discernible as distinct to the tumor by comparison to (i) samples from normal tissue in the same patient and (ii) databases of similar data for normal and other tumor types.
Time frame: Baseline
Putative mechanisms of action of the treatments that the patients received when they experienced their exceptional responses
The associations between identified molecular features and the putative mechanisms of action of the treatments that the patients received when they experienced their exceptional responses will be explored. Statistical analyses will be primarily descriptive.
Time frame: Baseline
Number of cases identified as potential exceptional responders
Statistical analyses will be primarily descriptive.
Time frame: Baseline
Percentage of identified potential cases confirmed to be exceptional responders
Statistical analyses will be primarily descriptive.
Time frame: Baseline
Percentage of confirmed exceptional responders for which adequate tissue with appropriate informed consent is acquired
Statistical analyses will be primarily descriptive.
Time frame: Baseline
Percentage of acquired cases with tissue for which at least the minimum molecular characterization is successfully obtained
Statistical analyses will be primarily descriptive.
Time frame: Baseline
Percentage of molecularly characterized cases for which a Molecular Characterization report identified (without reference to the drug received by the patient) at least one feature judged to have potential therapeutic relevance
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
Kaiser Permanente-Fresno
Fresno, California, United States
Kaiser Permanente-Oakland
Oakland, California, United States
Kaiser Permanente-Richmond
Richmond, California, United States
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States
Kaiser Permanente-Stockton
Stockton, California, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
...and 63 more locations
Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by an expert panel ("Panel") to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Time frame: Baseline
Percentage of cases with >= 1 feature on Molecular Characterization report that was judged to have potential therapeutic relevance to the specific class of drug the patient actually received when the exceptional response was experienced
Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by the Panel to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Time frame: Baseline
Percentage of cases with >= 1 feature that correlates with the mechanism of action of the specific grant to which the exceptional response occurred that was found after further analyzing the molecular profile data for relevant molecular abnormalities
Promising discoveries will be summarized for the group of cases for which the minimum molecular characterization was successfully obtained. For each such case, molecular data will be reviewed by the Panel to identify interesting features. All estimated proportions will be accompanied by exact 95% confidence intervals.
Time frame: Baseline