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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage II or III curative surgery (closed to accrual) | Patients with stage II or III solid tumors undergoing curative intend surgery enrolled before surgery. |
| |
| Stage II or III neoadjuvant therapy cohort (closed to accrual) | Patients with stage II or III solid tumors undergoing neoadjuvant therapy followed by curative intend surgery enrolled before neoadjuvant therapy. |
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| Metastatic disease | Patients with advanced, recurrent and/or metastatic disease requiring systemic therapy with chemotherapy, targeted therapy, immunotherapy or a combination of any before initiation of any therapy or a new line of therapy following documentation of disease progression on prior therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test | Diagnostic Test | No intervention except to collect blood for diagnostic test development |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the tumor load score and patient response to therapies. | Determination of a direct correlation between the tumor load score and patient response to therapies. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of particular mutation events which underlie the basis of any established correlation with therapy response. | To determine which particular mutation events underlie the basis of any established correlation with therapy response. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are (i) commencing or (ii) starting a new line of treatment for metastatic disease with any cytotoxic chemotherapy, targeted therapy, immunotherapy, a combination of any and/or radiation therapy. Patients with stage II or III solid tumors undergoing curative intend surgery or neoadjuvant therapy followed by surgery are also eligible, before surgery or initiation of neoadjuvant therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haluk Tezcan, MD | Contact | 530-863-7922 | htezcan@lexentbio.com | |
| Ayse Z Tezcan, Ph.D. | Contact | 530-863-7936 | atezcan@lexentbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Haluk Tezcan, MD | Lexent Bio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Care Associates | Recruiting | Torrance | California | 90277 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Blood 2 x 10 ml of Streck; FFPE tumor tissue (optional)