Circulating Tumor DNA Exposure in Peripheral Blood

Launched by QUANTGENE INC. · Apr 24, 2018

Keywords

ClinConnect Summary

This prospective, multi-center, feasibility study represents a feasibility study to determine the potential of circulating tumor DNA exposure in peripheral blood using a novel process in a sample of patients with different types of malignant organ tumors and a control cohort without malignant disease. The study applies a new process to detect ctDNA and other molecular markers in peripheral blood using: a collection of de-identified blood specimen and clinical data from up to 10,000 participants from clinical sites across the United States and Europe. Data collected will include the followin...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • This study will include subjects that are diagnosed with a malignancy (cohort
• • 1) and a negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2).
• * Subjects of both cohorts must:
• • Be of age ≥ 18
• • Provide written consent for study participation
• * Subject of cohort 1 must:
• • Have a diagnosis of a malignancy in clinical stage 0 to IV including but not limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, bladder cancer, melanoma
• Subjects of cohort 2 must:
• • • Meet the listed matching criteria
• Exclusion Criteria:
• • Subjects of cohort 1 must not: Have been treated for above diagnosed malignancy
• * Subjects of cohort 2 must not:
• • Have been diagnosed/treated for a malignancy previously