Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method
NCT ID: NCT02025413
Last Updated: 2018-12-20
Study Results
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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COMPLETED
NA
46 participants
INTERVENTIONAL
2011-11-30
2015-12-31
Brief Summary
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The primary objective of each comparative cohort (second stage, prostate cancer) is to compare the non-detection rate of circulating tumor cells between the standard and novel methods.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Metastatic progressive castration-resistant prostate cancer
Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
Metastatic progressive breast cancer
Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
Interventions
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Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
Eligibility Criteria
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Inclusion Criteria
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. Evidence of disease progression on or following most recent therapy as evidenced clinically by the treating physician or by either of the following:
* Two consecutive PSA levels greater than the PSA nadir achieved on ADT, 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).
5. Age \> 18 years.
6. Ability to understand and the willingness to sign a written informed consent document.
1. Histologically confirmed diagnosis of invasive breast cancer.
2. Clinical or radiographic evidence of metastatic disease.
3. Evidence of disease progression on the current or following the most recent therapy, determined either clinically by the treating physician or by radiographic evidence as defined by new bone scan lesions or soft tissue/visceral metastases \>1 cm in diameter (2 cm for lymph nodes).
4. Age \> 18 years.
5. Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
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 or mitoxantrone within 1 week of CTC collection
18 Years
ALL
No
Sponsors
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Prostate Cancer Foundation
OTHER
United States Department of Defense
FED
Janssen Diagnostics, LLC
INDUSTRY
Duke University
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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Pro00032772
Identifier Type: -
Identifier Source: org_study_id