Spots Global Cancer Trial Database for Development of a Cell Free DNA Assay as a Biomarker for Predicting Early Non-response to Therapy in Metastatic Cancer
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Trial Identification
Brief Title: Development of a Cell Free DNA Assay as a Biomarker for Predicting Early Non-response to Therapy in Metastatic Cancer
Official Title: Development of a Cell Free DNA Assay as a Biomarker for Predicting Early Non-response to Therapy in Metastatic Cancer
Study ID: NCT03892096
Interventions
Study Description
Brief Summary: Accrue samples for the further development and clinical validation of a blood-based cell-free DNA (cfDNA) quantitative real-time polymerase chain reaction (qPCR) assay as a potential biomarker for early non-response to therapy in stage IV non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer (BC).
Detailed Description: Most anticancer drugs are effective only in subgroups of patients, and our current understanding of tumor biology does not allow us to predict accurately which patient will benefit from a specific therapeutic regimen. The definitive proof of the effectiveness of a therapy is improvement in clinical symptoms and survival. Imaging is generally used to assess therapeutic effects earlier and more objectively. Current response assessment is based primarily on changes in tumor size as measured by CT or other anatomic imaging modalities. Cadex Genomics has developed an analytically validated cell-free DNA (cfDNA) quantitative real-time polymerase chain reaction (qPCR) assay that utilizes standard qPCR platforms for processing, this test can reliably obtain results from small blood volumes and possesses exceptionally high analytical sensitivity of circulating cfDNA. The purpose of this study is to accrue samples for the further development and clinical validation of a blood-based cell-free cfDNA qPCR assay as a potential biomarker for early non-response to therapy in stage IV non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and breast cancer (BC).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CARTI Cancer Center, Little Rock, Arkansas, United States
Sutter Health - Palo Alto Medical Foundation, Sunnyvale, California, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
IACT Health, Columbus, Georgia, United States
University Medical Center, New Orleans, Louisiana, United States
Southeast Louisiana Veterans Health Care System, New Orleans, Louisiana, United States
Nebraska Cancer Center, Omaha, Nebraska, United States
National Translational Research Group LLC, Port Jefferson Station, New York, United States
Waverly Hematology Oncology, Cary, North Carolina, United States
Advent Health, Hendersonville, North Carolina, United States
Greenville Health System - Prisma Health, Greenville, South Carolina, United States
McGill University, Montréal, Quebec, Canada
Contact Details
Name: Christer Svedman, M.D. Ph.D.
Affiliation: Cadex Genomics
Role: STUDY_DIRECTOR
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