tDNA Registry

Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study

September 18, 2018

  • Clinical Trial Information

    Trial Contact: Caparas, Maria-Lourdes; De Leon, Ma Theresa

    Trial Phone: 321.841.3498 ; 321.841.8284

  • IRB No: 18.100.08

    Protocol Abbrev: tDNA Registry_

    Principal Investigator: Debashish Bose, MD

    Age Group: Adult

    Secondary Protocol No: Quantgene Study

    Treatment: This is a registry study, there is no drug.

    ClinicalTrials.gov ID: NCT03517332

  • Objective

    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).

  • Key Eligibility

    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