Detection of Tumor DNA in Blood Samples From Patients With Early Stage Cancer and "Healthy Controls"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasms, Non-hematologic - Stage I-III
- Sponsor
- Lexent Bio, Inc.
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Detection of signal in the presence of active neoplasm
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor-derived nucleic acids in the blood of patients diagnosed with an early stage solid tumor who are either commencing, currently undergoing or have completed treatment. This approach will allow the investigators to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.
Detailed Description
The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor-derived nucleic acids in the blood of patients diagnosed with an early stage solid tumor who are either commencing, currently undergoing or have completed treatment. This approach will allow the investigators to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment. The presence of circulating tumor-derived cfDNA in the plasma of patients can potentially enable a non-invasive means of detecting the presence or absence of tumor, assessing tumor burden and characterizing tumor biology in patients with cancer. The ability to measure the distribution of circulating tumor DNA may allow determination of a quantitative tumor load score in plasma that correlates to clinical tumor load. Clinical tumor load is a measure of disease burden, and the investigators propose to test in this study whether the tumor load score can measure this disease burden. A simple, reliable measure of disease burden would have diverse utility during patient therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For all participants:
- •Age 18 years or older
- •Able to understand and grant informed consent
- •Able to have their blood drawn at enrollment before surgery and 7 to 28 days after surgery
- •For participants with early stage solid tumors:
- •Diagnosed with an early stage (I-III) solid tumor with curative intent surgery without neoadjuvant therapy planned
- •For "healthy control" subgroup:
- •No prior or current diagnosis of any cancer. Participants with prior in situ cancer or non-melanoma skin cancer will be allowed to participate but will not be included in the "healthy control" cohort and will be analyzed separately.
Exclusion Criteria
- •Unable to grant informed consent or comply with all study procedures
- •Diagnosed with a hematological malignancy (acute or chronic leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, myeloma or lymphoma).
Outcomes
Primary Outcomes
Detection of signal in the presence of active neoplasm
Time Frame: 2 years
To determine the association between the tumor load score and clinical tumor load as assessed with the current standard of care methods and pathology findings.
Determine change in signal after surgery
Time Frame: 5 years
To determine the response of tumor load score as a function of tumor presence as determined pre- and post-surgery intended to be curative