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Exceptional Responders Pilot Study: Molecular Profiling of Tumors From Cancer Patients Who Are Exceptional Responders
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
September 24, 2014
Primary Completion Date
March 4, 2021
Completion Date
April 2, 2026
Last Updated
March 20, 2026
170
ACTUAL participants
Laboratory Biomarker Analysis
OTHER
Lead Sponsor
National Cancer Institute (NCI)
NCT00026884
NCT04585750
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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