Prostate CancerNCT02080650
Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)
A study testing Mesenchymal-marker based ferrofluid (c-MET) and Epithelial cell adhesion molecule (EpCAM) ferrofluid in people with Prostate Cancer and Renal Cell Carcinoma, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Renal Cell Carcinoma, Bladder Cancer
- What is being tested?
- Mesenchymal-marker based ferrofluid (c-MET) and Epithelial cell adhesion molecule (EpCAM) ferrofluid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 19 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 75Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
- Conditions
- Prostate Cancer, Renal Cell Carcinoma, Bladder Cancer, Colorectal Cancer, Gastric Cancer, Pancreatic Cancer
- Being tested
- Mesenchymal-marker based ferrofluid (c-MET), Epithelial cell adhesion molecule (EpCAM) ferrofluid
- Medical subject headings
- Prostatic Neoplasms, Carcinoma, Renal Cell, Urinary Bladder Neoplasms, Colorectal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal-marker based ferrofluid (c-MET)Device
Epithelial cell adhesion molecule (EpCAM) ferrofluidDevice
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer | Other | Mesenchymal-marker based ferrofluid (c-MET) Receives: Device: Mesenchymal-marker based ferrofluid (c-MET); Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid |
| Renal cell carcinoma | Other | Mesenchymal-marker based ferrofluid (c-MET) Receives: Device: Mesenchymal-marker based ferrofluid (c-MET); Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid |
| Bladder cancer | Other | Mesenchymal-marker based ferrofluid (c-MET) Receives: Device: Mesenchymal-marker based ferrofluid (c-MET); Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid |
| Gastric cancer | Other | Mesenchymal-marker based ferrofluid (c-MET) Receives: Device: Mesenchymal-marker based ferrofluid (c-MET); Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid |
| Colorectal cancer | Other | Mesenchymal-marker based ferrofluid (c-MET) Receives: Device: Mesenchymal-marker based ferrofluid (c-MET); Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid |
| Pancreatic cancer | Other | Mesenchymal-marker based ferrofluid (c-MET) Receives: Device: Mesenchymal-marker based ferrofluid (c-MET); Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid |
| Non-small cell lung cancer | Other | Mesenchymal-marker based ferrofluid (c-MET) Receives: Device: Mesenchymal-marker based ferrofluid (c-MET); Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid |
| Advanced MET amplified solid tumor | Other | Mesenchymal-marker based ferrofluid (c-MET) Receives: Device: Mesenchymal-marker based ferrofluid (c-MET); Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects within each disease site.
Measured: day 1
Secondary outcomes (3)
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.
Measured: day 1
Association of the number of detectable CTCs with baseline clinical and pathologic disease characteristics.
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion19 May 2016
- Study completion19 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Foundation, Janssen Diagnostics, LLC
- Responsible party
- Sponsor
- Investigators
- Andrew J Armstrong, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080650
- Sponsor's protocol ID
- Pro00052149
- Status last verified
- Jul 2017
- First submitted
- 3 Mar 2014
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)
- ClinicalTrials.gov ID
- NCT02080650
- Acronym / sponsor ID
- Pro00052149
- Conditions
- Prostate Cancer, Renal Cell Carcinoma, Bladder Cancer, Colorectal Cancer, Gastric Cancer, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Prostate Cancer Foundation, Janssen Diagnostics, LLC
- Study start
- Mar 2014
- Primary completion
- 19 May 2016 (actual)
- Study completion
- 19 Jul 2016 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer | Other | Device: Mesenchymal-marker based ferrofluid (c-MET), Device: Epithelial cell adhesion molecule (EpCAM) ferrofluidMesenchymal-marker based ferrofluid (c-MET) |
| Renal cell carcinoma | Other | Device: Mesenchymal-marker based ferrofluid (c-MET), Device: Epithelial cell adhesion molecule (EpCAM) ferrofluidMesenchymal-marker based ferrofluid (c-MET) |
| Bladder cancer | Other | Device: Mesenchymal-marker based ferrofluid (c-MET), Device: Epithelial cell adhesion molecule (EpCAM) ferrofluidMesenchymal-marker based ferrofluid (c-MET) |
| Gastric cancer | Other | Device: Mesenchymal-marker based ferrofluid (c-MET), Device: Epithelial cell adhesion molecule (EpCAM) ferrofluidMesenchymal-marker based ferrofluid (c-MET) |
| Colorectal cancer | Other | Device: Mesenchymal-marker based ferrofluid (c-MET), Device: Epithelial cell adhesion molecule (EpCAM) ferrofluidMesenchymal-marker based ferrofluid (c-MET) |
| Pancreatic cancer | Other | Device: Mesenchymal-marker based ferrofluid (c-MET), Device: Epithelial cell adhesion molecule (EpCAM) ferrofluidMesenchymal-marker based ferrofluid (c-MET) |
| Non-small cell lung cancer | Other | Device: Mesenchymal-marker based ferrofluid (c-MET), Device: Epithelial cell adhesion molecule (EpCAM) ferrofluidMesenchymal-marker based ferrofluid (c-MET) |
| Advanced MET amplified solid tumor | Other | Device: Mesenchymal-marker based ferrofluid (c-MET), Device: Epithelial cell adhesion molecule (EpCAM) ferrofluidMesenchymal-marker based ferrofluid (c-MET) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (75 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal-marker based ferrofluid (c-MET) | Device | Advanced MET amplified solid tumor, Bladder cancer, Colorectal cancer, Gastric cancer, Non-small cell lung cancer, Pancreatic cancer, Prostate cancer, Renal cell carcinoma |
| Epithelial cell adhesion molecule (EpCAM) ferrofluid | Device | Advanced MET amplified solid tumor, Bladder cancer, Colorectal cancer, Gastric cancer, Non-small cell lung cancer, Pancreatic cancer, Prostate cancer, Renal cell carcinoma |
Primary outcome
Feasibility
Time frame: day 1
Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects within each disease site.
3 secondary outcomes
Difference in the median number of CTCs
Time frame: day 1
Association of the number of detectable CTCs with baseline clinical and pathologic disease characteristics.
Time frame: day 1
Kinetics of CTCs over time during treatment with c-MET targeted therapies
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Armstrong, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesenchymal-marker based ferrofluid (c-MET) and Epithelial cell adhesion molecule (EpCAM) ferrofluid in people with Prostate Cancer and Renal Cell Carcinoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 75 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.