Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study
Clinical Trial Information
Trial Contact: De Leon, Ma Theresa; Jarquin-Castillo, Katherine
IRB No: 18.100.08
Protocol Abbrev: tDNA Registry_
Principal Investigator: Bose, Debashish, MD
Age Group: Adult
Secondary Protocol No: Quantgene Study
Treatment: This is a registry study, there is no drug.
ClinicalTrials.gov ID: NCT03517332
This is a prospective, multi-center, blinded feasibility study. The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).
• 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