Phase
Condition
Gastric Cancer
Renal Cell Carcinoma
Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Prostate cancer patients will be eligible for inclusion in this study only if all of thefollowing criteria apply:
Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell orneuroendocrine 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 byeither of the following:
Two consecutive PSA levels greater than the PSA nadir achieved on ADT and mostrecent therapy, separated by greater than one week
Radiographic evidence of disease progression as defined by new bone scan lesionsor growth of soft tissue/visceral metastases >1 cm in diameter (2 cm for lymphnodes).
Clinical progression of disease with cutaneous lesions or palpable lesions inabsence 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 ofthe 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 determinedby the investigator
Clinical progression of disease with cutaneous lesions or palpable lesions inabsence of radiographic progression
For clear cell carcinoma, refractory to treatment with VEGF inhibitors as defined byprogression on VEGF therapy within 1 year of starting VEGF therapy. For non-clear cellhistologies, 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 thefollowing 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 clinicallysymptomatic with metastatic disease.
Progression of disease on or following the most recent treatment as evidenced by oneof the following:
A new soft tissue/visceral/lymph node/bone metastatic lesion
Growth of existing soft tissue/visceral/lymph node/bone metastases as determinedby the investigator.
Clinical progression of disease with cutaneous lesions, palpable lesions, pleuraleffusions, 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 forinclusion in this study only if all of the following inclusion criteria apply:
Histologically confirmed diagnosis of invasive gastric or distal esophagealadenocarcinoma.
Clinical or radiographic evidence of metastatic disease.
Evidence of disease progression on or following the most recent therapy, as defined byone of the following:
New soft tissue/visceral/lymph node/bone metastatic lesion
Growth of existing soft tissue/visceral/lymph node/bone metastases as determinedby the investigator
Clinical progression of disease with cutaneous lesions, palpable lesions, pleuraleffusions, 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 thefollowing 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 determinedby the investigator
Clinical progression of disease with cutaneous lesions, palpable lesions, pleuraleffusions, 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 thefollowing 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 studyonly 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 theinvestigator.
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 studyonly 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 clinicallysymptomatic with metastatic disease.
Progression of disease on or following the most recent treatment as evidenced by oneof the following:
A new soft tissue/visceral/lymph node/bone metastatic lesion
Growth of existing soft tissue/visceral/lymph node/bone metastases as determinedby the investigator.
Clinical progression of disease with cutaneous lesions or palpable lesions inabsence of radiographic progression
Progression of disease either on or following treatment with an EGFR inhibitor (suchas 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
Exclusion Criteria: A patient will not be eligible for inclusion in this study if any of the following criteriaapply:
History of intercurrent or past medical or psychiatric illness that would makeparticipation in a blood drawing protocol difficult or not feasible at the discretionof the principal investigator or co-investigator(s).
Treatment with an anthracycline (including mitoxantrone, doxorubicin, epirubicin, anddaunorubicin) within 1 week of CTC collection (applicable in prostate and gastriccancer patients), as anthracyclines cause auto-fluorescence of cells.
Study Design
Connect with a study center
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available

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