Clinical Trials Directory

Trials / Completed

CompletedNCT03892096

Development of a Cell Free DNA Assay as a Biomarker for Predicting Early Non-response to Therapy in Metastatic Cancer

Status
Completed
Phase
—
Study type
Observational
Enrollment
130 (actual)
Sponsor
Cadex Genomics · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTBlood-based cell-free cfDNA qPCR assayUp to 30mL of blood via venipuncture

Timeline

Start date
2019-03-01
Primary completion
2023-11-15
Completion
2024-02-06
First posted
2019-03-27
Last updated
2024-02-07

Locations

12 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT03892096. Inclusion in this directory is not an endorsement.