NCT02288754
Unknown
Not Applicable
Detection of Tumor DNA in Blood Samples From Patients With Late Stage Cancer and "Healthy Controls"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Lexent Bio, Inc.
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Correlation between the tumor load score and patient response to therapies.
- 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 nucleic acids in the blood of a cancer patient with diagnosed metastatic disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy treatment. More generally, this approach will allow us to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older
- •Have metastatic disease with from a solid tumor (e.g. breast, lung, colon, pancreas, ovary, prostate...) or stage II or III solid tumors undergoing curative surgery or neoadjuvant therapy followed by surgery
- •Starting treatment or a new line of treatment
- •Able to understand and grant informed consent
- •Able to have their blood drawn
Exclusion Criteria
- •Unable to grant informed consent or comply with all study procedures.
- •Has a hematological malignancy, i.e. myeloma, lymphoma, MDS, leukemia
Outcomes
Primary Outcomes
Correlation between the tumor load score and patient response to therapies.
Time Frame: 5 years
Determination of a direct correlation between the tumor load score and patient response to therapies.
Secondary Outcomes
- Determination of particular mutation events which underlie the basis of any established correlation with therapy response.(5 years)
Study Sites (1)
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