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| Name | Class |
|---|---|
| Prostate Cancer Foundation | OTHER |
| Janssen Diagnostics, LLC | INDUSTRY |
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This pilot study will aim to determine whether circulating tumor cells (CTCs) can be captured using the novel cMET based ferrofluid. The primary objective of this pilot study will be to describe the numbers of c-MET expressing cells that can be detected by the c-MET CTC capture technique. These data will be separated by disease site. The investigator will also describe the detection rates of both the c-MET CTC capture and the EpCAM CTC capture techniques in each patient, also separated by disease site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate cancer | Other | Mesenchymal-marker based ferrofluid (c-MET) |
|
| Renal cell carcinoma | Other | Mesenchymal-marker based ferrofluid (c-MET) |
|
| Bladder cancer | Other | Mesenchymal-marker based ferrofluid (c-MET) |
|
| Gastric cancer | Other | Mesenchymal-marker based ferrofluid (c-MET) |
|
| Colorectal cancer | Other | Mesenchymal-marker based ferrofluid (c-MET) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal-marker based ferrofluid (c-MET) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects within each disease site. | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the median number of CTCs | The difference in the median number of CTCs detected by each of the capture methods (novel and standard) will be calculated. | day 1 |
| Association of the number of detectable CTCs with baseline clinical and pathologic disease characteristics. |
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Inclusion Criteria:
Prostate cancer patients will be eligible for inclusion in this study only if all of the following criteria apply:
Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.
Clinical or radiographic evidence of metastatic disease.
Castrate levels of testosterone (<50 ng/dl)
Enrollment prior to the initiation of a new systemic therapy.
Evidence of disease progression on or following most recent therapy as evidenced by either of the following:
Age > 18 years.
Ability to understand and the willingness to sign a written informed consent document.
Renal cell carcinoma patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:
Histologically confirmed diagnosis of invasive renal cell carcinoma (all histologies)
Clinical or radiographic evidence of metastatic disease.
Evidence of disease progression on the current or following the most recent therapy, as defined by one of the following:
For clear cell carcinoma, refractory to treatment with VEGF inhibitors as defined by progression on VEGF therapy within 1 year of starting VEGF therapy. For non-clear cell histologies, any line of systemic therapy.
Enrollment prior to the initiation of a new systemic therapy.
Age > 18 years.
Ability to understand and the willingness to sign a written informed consent document.
Bladder cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:
Histologically confirmed diagnosis of invasive bladder transitional cell carcinoma, adenocarcinoma, squamous cell carcinoma, or small cell carcinoma.
Metastatic disease with either bone or visceral metastatic lesions, or clinically symptomatic with metastatic disease.
Progression of disease on or following the most recent treatment as evidenced by one of the following:
Enrollment prior to the initiation of a new systemic therapy.
Age > 18 years.
Ability to understand and the willingness to sign a written informed consent document.
Gastric cancer (including gastroesophageal junction) patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:
Histologically confirmed diagnosis of invasive gastric or distal esophageal adenocarcinoma.
Clinical or radiographic evidence of metastatic disease.
Evidence of disease progression on or following the most recent therapy, as defined by one of the following:
Enrollment prior to the initiation of a new systemic therapy.
Age > 18 years.
Ability to understand and the willingness to sign a written informed consent document.
Colorectal cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:
Histologically confirmed diagnosis of invasive colorectal adenocarcinoma.
Clinical or radiographic evidence of metastatic disease.
Evidence of disease progression on the current or following the most recent therapy, as defined by one of the following:
Enrollment prior to the initiation of a new systemic therapy.
Age > 18 years.
Ability to understand and the willingness to sign a written informed consent document.
Pancreatic cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:
Advanced, MET amplified, solid tumor patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:
Non-Small Cell Lung Cancer (NSCLC) patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:
Histologically confirmed diagnosis of invasive non-small cell carcinoma of the lung (includes adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous, and carcinomas with pleomorphic, sarcomatoid, or sarcomatous elements; does not include carcinoid tumor or neuroendocrine carcinoma).
Metastatic disease with either bone or visceral metastatic lesions, or clinically symptomatic with metastatic disease.
Progression of disease on or following the most recent treatment as evidenced by one of the following:
Progression of disease either on or following treatment with an EGFR inhibitor (such as erlotinib, gefitinib, or other EGFR-targeted therapy)
Enrollment prior to the initiation of a new systemic therapy.
Age > 18 years.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
A patient will not be eligible for inclusion in this study if any of the following criteria apply:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew J Armstrong, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| Pancreatic cancer | Other | Mesenchymal-marker based ferrofluid (c-MET) |
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| Non-small cell lung cancer | Other | Mesenchymal-marker based ferrofluid (c-MET) |
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| Advanced MET amplified solid tumor | Other | Mesenchymal-marker based ferrofluid (c-MET) |
|
| Epithelial cell adhesion molecule (EpCAM) ferrofluid | Device |
|
Within each method, the patient will be used as the unit of observation to describe the association of number of detectable CTC cells with the following baseline characteristics: TNM staging, site of metastases (e.g., bone, liver, lymph nodes), Gleason sum (for PC), PSA (for PC), the number of prior hormone therapies (in PC), CEA (for colorectal cancer), the use of previous EGFR inhibitors and KRAS mutation status (for colorectal cancer), HER2 status and prior HER2 treatments (for gastric cancer), CA 19-9 (for pancreatic cancer), and number of prior chemotherapies. |
| day 1 |
| Kinetics of CTCs over time during treatment with c-MET targeted therapies | Change is CTCs in patients with MET amplified tumors undergoing treatment with c-MET targeted therapies will be calculated. | 8 weeks |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D001749 | Urinary Bladder Neoplasms |
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D001745 | Urinary Bladder Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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