Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)

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:

• Two consecutive PSA levels greater than the PSA nadir achieved on ADT and most recent therapy, separated by greater than one week
• Radiographic evidence of disease progression as defined by new bone scan lesions or growth of soft tissue/visceral metastases >1 cm in diameter (2 cm for lymph nodes).
• Clinical progression of disease with cutaneous lesions or palpable lesions in absence of radiographic progression
• 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:

• A new soft tissue/visceral/lymph node/bone metastatic lesion
• Growth of existing soft tissue/visceral/lymph node/bone metastases as determined by the investigator
• Clinical progression of disease with cutaneous lesions or palpable lesions in absence of radiographic progression
• 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:

• A new soft tissue/visceral/lymph node/bone metastatic lesion
• Growth of existing soft tissue/visceral/lymph node/bone metastases as determined by the investigator.
• Clinical progression of disease with cutaneous lesions, palpable lesions, pleural effusions, or ascites in absence of radiographic progression
• 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:

• New soft tissue/visceral/lymph node/bone metastatic lesion
• Growth of existing soft tissue/visceral/lymph node/bone metastases as determined by the investigator
• Clinical progression of disease with cutaneous lesions, palpable lesions, pleural effusions, or ascites in absence of radiographic progression
• 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:

• New soft tissue/visceral/lymph node/bone metastatic lesion
• Growth of existing soft tissue/visceral/lymph node/bone metastases as determined by the investigator
• Clinical progression of disease with cutaneous lesions, palpable lesions, pleural effusions, or ascites in absence of radiographic progression
• 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:

• Histologically confirmed diagnosis of invasive pancreatic adenocarcinoma.
• Clinical or radiographic evidence of metastatic disease.
• 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.

Advanced, MET amplified, solid tumor patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:

• Histologically confirmed diagnosis of cancer (any kind)
• MET gene amplification by FISH, CISH, rtPCR, or other assay as determined by the investigator.
• Clinical or radiographic evidence of metastatic disease.
• Age > 18 years.
• Ability to understand and the willingness to sign a written informed consent document.

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:

• A new soft tissue/visceral/lymph node/bone metastatic lesion
• Growth of existing soft tissue/visceral/lymph node/bone metastases as determined by the investigator.
• Clinical progression of disease with cutaneous lesions or palpable lesions in absence of radiographic progression
• 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:

• History of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s).
• Treatment with an anthracycline (including mitoxantrone, doxorubicin, epirubicin, and daunorubicin) within 1 week of CTC collection (applicable in prostate and gastric cancer patients), as anthracyclines cause auto-fluorescence of cells.