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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early stage neoplasm | Patients with stage I-III early stage non-hematologic neoplasm | ||
| Healthy Control | Patients undergoing surgery for a non-malignant condition with no prior history of malignancy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Detection of signal in the presence of active neoplasm | 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. | 2 years |
| Determine change in signal after surgery | To determine the response of tumor load score as a function of tumor presence as determined pre- and post-surgery intended to be curative | 5 years |
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Inclusion Criteria:
1. For all participants:
For participants with early stage solid tumors:
For "healthy control" subgroup:
Exclusion Criteria:
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Up to 200 patients from multiple clinical sites will be enrolled in this study. Patients are eligible for this study if they are diagnosed with a solid tumor and undergoing curative resection. In addition, up to 200 participants with no prior or current diagnosis of cancer will be enrolled as a control group, i.e. "healthy control," for assay development.
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| Name | Affiliation | Role |
|---|---|---|
| Haluk Tezcan, MD | Lexent Bio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alisa Williams, MD Inc | San Diego | California | 92103 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018204 | Neoplasms, Connective and Soft Tissue |
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Whole Blood; FFPE (optional)