Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)
NCT ID: NCT02080650
Last Updated: 2017-08-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
62 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-03-31
Study Completion Date
2016-07-19
Brief Summary
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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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Detailed Description
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Conditions
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Prostate Cancer
Renal Cell Carcinoma
Bladder Cancer
Colorectal Cancer
Gastric Cancer
Pancreatic Cancer
Non-small Cell Lung Cancer
Advanced MET Amplified Solid Tumor
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
DEVICE_FEASIBILITY
Blinding Strategy
NONE
Study Groups
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Prostate cancer
Mesenchymal-marker based ferrofluid (c-MET)
Group Type
OTHER
Mesenchymal-marker based ferrofluid (c-MET)
Intervention Type
DEVICE
Epithelial cell adhesion molecule (EpCAM) ferrofluid
Intervention Type
DEVICE
Renal cell carcinoma
Mesenchymal-marker based ferrofluid (c-MET)
Group Type
OTHER
Mesenchymal-marker based ferrofluid (c-MET)
Intervention Type
DEVICE
Epithelial cell adhesion molecule (EpCAM) ferrofluid
Intervention Type
DEVICE
Bladder cancer
Mesenchymal-marker based ferrofluid (c-MET)
Group Type
OTHER
Mesenchymal-marker based ferrofluid (c-MET)
Intervention Type
DEVICE
Epithelial cell adhesion molecule (EpCAM) ferrofluid
Intervention Type
DEVICE
Gastric cancer
Mesenchymal-marker based ferrofluid (c-MET)
Group Type
OTHER
Mesenchymal-marker based ferrofluid (c-MET)
Intervention Type
DEVICE
Epithelial cell adhesion molecule (EpCAM) ferrofluid
Intervention Type
DEVICE
Colorectal cancer
Mesenchymal-marker based ferrofluid (c-MET)
Group Type
OTHER
Mesenchymal-marker based ferrofluid (c-MET)
Intervention Type
DEVICE
Epithelial cell adhesion molecule (EpCAM) ferrofluid
Intervention Type
DEVICE
Pancreatic cancer
Mesenchymal-marker based ferrofluid (c-MET)
Group Type
OTHER
Mesenchymal-marker based ferrofluid (c-MET)
Intervention Type
DEVICE
Epithelial cell adhesion molecule (EpCAM) ferrofluid
Intervention Type
DEVICE
Non-small cell lung cancer
Mesenchymal-marker based ferrofluid (c-MET)
Group Type
OTHER
Mesenchymal-marker based ferrofluid (c-MET)
Intervention Type
DEVICE
Epithelial cell adhesion molecule (EpCAM) ferrofluid
Intervention Type
DEVICE
Advanced MET amplified solid tumor
Mesenchymal-marker based ferrofluid (c-MET)
Group Type
OTHER
Mesenchymal-marker based ferrofluid (c-MET)
Intervention Type
DEVICE
Epithelial cell adhesion molecule (EpCAM) ferrofluid
Intervention Type
DEVICE
Interventions
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Mesenchymal-marker based ferrofluid (c-MET)
Intervention Type
DEVICE
Epithelial cell adhesion molecule (EpCAM) ferrofluid
Intervention Type
DEVICE
Eligibility Criteria
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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:
1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.
2. Clinical or radiographic evidence of metastatic disease.
3. Castrate levels of testosterone (\<50 ng/dl)
4. Enrollment prior to the initiation of a new systemic therapy.
5. 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
6. Age \> 18 years.
7. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of invasive renal cell carcinoma (all histologies)
2. Clinical or radiographic evidence of metastatic disease.
3. 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
4. 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.
5. Enrollment prior to the initiation of a new systemic therapy.
6. Age \> 18 years.
7. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of invasive bladder transitional cell carcinoma, adenocarcinoma, squamous cell carcinoma, or small cell carcinoma.
2. Metastatic disease with either bone or visceral metastatic lesions, or clinically symptomatic with metastatic disease.
3. 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
4. Enrollment prior to the initiation of a new systemic therapy.
5. Age \> 18 years.
6. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of invasive gastric or distal esophageal adenocarcinoma.
2. Clinical or radiographic evidence of metastatic disease.
3. 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
4. Enrollment prior to the initiation of a new systemic therapy.
5. Age \> 18 years.
6. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of invasive colorectal adenocarcinoma.
2. Clinical or radiographic evidence of metastatic disease.
3. 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
4. Enrollment prior to the initiation of a new systemic therapy.
5. Age \> 18 years.
6. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of invasive pancreatic adenocarcinoma.
2. Clinical or radiographic evidence of metastatic disease.
3. Enrollment prior to the initiation of a new systemic therapy.
4. Age \> 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of cancer (any kind)
2. MET gene amplification by FISH, CISH, rtPCR, or other assay as determined by the investigator.
3. Clinical or radiographic evidence of metastatic disease.
4. Age \> 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.
1. 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).
2. Metastatic disease with either bone or visceral metastatic lesions, or clinically symptomatic with metastatic disease.
3. 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
4. Progression of disease either on or following treatment with an EGFR inhibitor (such as erlotinib, gefitinib, or other EGFR-targeted therapy)
5. Enrollment prior to the initiation of a new systemic therapy.
6. Age \> 18 years.
7. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted.
2. Clinical or radiographic evidence of metastatic disease.
3. Castrate levels of testosterone (\<50 ng/dl)
4. Enrollment prior to the initiation of a new systemic therapy.
5. 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
6. Age \> 18 years.
7. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of invasive renal cell carcinoma (all histologies)
2. Clinical or radiographic evidence of metastatic disease.
3. 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
4. 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.
5. Enrollment prior to the initiation of a new systemic therapy.
6. Age \> 18 years.
7. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of invasive bladder transitional cell carcinoma, adenocarcinoma, squamous cell carcinoma, or small cell carcinoma.
2. Metastatic disease with either bone or visceral metastatic lesions, or clinically symptomatic with metastatic disease.
3. 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
4. Enrollment prior to the initiation of a new systemic therapy.
5. Age \> 18 years.
6. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of invasive gastric or distal esophageal adenocarcinoma.
2. Clinical or radiographic evidence of metastatic disease.
3. 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
4. Enrollment prior to the initiation of a new systemic therapy.
5. Age \> 18 years.
6. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of invasive colorectal adenocarcinoma.
2. Clinical or radiographic evidence of metastatic disease.
3. 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
4. Enrollment prior to the initiation of a new systemic therapy.
5. Age \> 18 years.
6. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of invasive pancreatic adenocarcinoma.
2. Clinical or radiographic evidence of metastatic disease.
3. Enrollment prior to the initiation of a new systemic therapy.
4. Age \> 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of cancer (any kind)
2. MET gene amplification by FISH, CISH, rtPCR, or other assay as determined by the investigator.
3. Clinical or radiographic evidence of metastatic disease.
4. Age \> 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.
1. 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).
2. Metastatic disease with either bone or visceral metastatic lesions, or clinically symptomatic with metastatic disease.
3. 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
4. Progression of disease either on or following treatment with an EGFR inhibitor (such as erlotinib, gefitinib, or other EGFR-targeted therapy)
5. Enrollment prior to the initiation of a new systemic therapy.
6. Age \> 18 years.
7. 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:
1. 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).
2. 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.
1. 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).
2. 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Prostate Cancer Foundation
OTHER
Sponsor Role
collaborator
Janssen Diagnostics, LLC
INDUSTRY
Sponsor Role
collaborator
Duke University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Andrew J Armstrong, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Site Status
Countries
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United States
Other Identifiers
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Pro00052149
Identifier Type: -
Identifier Source: org_study_id
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