Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)
1 other identifier
interventional
62
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 3, 2014
CompletedFirst Posted
Study publicly available on registry
March 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2016
CompletedAugust 1, 2017
July 1, 2017
2.2 years
March 3, 2014
July 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Difference in the median number of CTCs
day 1
Association of the number of detectable CTCs with baseline clinical and pathologic disease characteristics.
day 1
Kinetics of CTCs over time during treatment with c-MET targeted therapies
8 weeks
Study Arms (8)
Prostate cancer
OTHERMesenchymal-marker based ferrofluid (c-MET)
Renal cell carcinoma
OTHERMesenchymal-marker based ferrofluid (c-MET)
Bladder cancer
OTHERMesenchymal-marker based ferrofluid (c-MET)
Gastric cancer
OTHERMesenchymal-marker based ferrofluid (c-MET)
Colorectal cancer
OTHERMesenchymal-marker based ferrofluid (c-MET)
Pancreatic cancer
OTHERMesenchymal-marker based ferrofluid (c-MET)
Non-small cell lung cancer
OTHERMesenchymal-marker based ferrofluid (c-MET)
Advanced MET amplified solid tumor
OTHERMesenchymal-marker based ferrofluid (c-MET)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
- +52 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Prostate Cancer Foundationcollaborator
- Janssen Diagnostics, LLCcollaborator
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew J Armstrong, MD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2014
First Posted
March 6, 2014
Study Start
March 1, 2014
Primary Completion
May 19, 2016
Study Completion
July 19, 2016
Last Updated
August 1, 2017
Record last verified: 2017-07