Back to resultsIsolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method (CTC-EMT)
Primary Purpose
Metastatic Progressive Castration-resistant Prostate Cancer, Metastatic Progressive Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
Sponsored by
About this trial
This is an interventional device feasibility trial for Metastatic Progressive Castration-resistant Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
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)
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).
- Age > 18 years.
- Ability to understand and the willingness to sign a written informed consent document.
Breast cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:
- Histologically confirmed diagnosis of invasive breast cancer.
- Clinical or radiographic evidence of metastatic disease.
- 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).
- Age > 18 years.
- 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:
- 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 or mitoxantrone within 1 week of CTC collection
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Metastatic progressive castration-resistant prostate cancer
Metastatic progressive breast cancer
Arm Description
Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
Outcomes
Primary Outcome Measures
Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects, comparing the non-detection rate over time.
Secondary Outcome Measures
Comparison of the proportion of patients with no detectable CTCs between capture methods over time
Changes in CTCs (using each method) over time during systemic therapy
Change in correlation of CTC enumeration using each method with baseline clinical and pathologic disease characteristics (for example, clinical stage, site of metastatic disease, Gleason sum for CRPC, PSA for CRPC, previous therapies)
Median number of CTCs detected by each method over time
Full Information
NCT ID
NCT02025413
First Posted
December 19, 2013
Last Updated
December 19, 2018
Sponsor
Duke University
Collaborators
Prostate Cancer Foundation, United States Department of Defense, Janssen Diagnostics, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02025413
Brief Title
Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method
Acronym
CTC-EMT
Official Title
Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Prostate Cancer Foundation, United States Department of Defense, Janssen Diagnostics, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of the preliminary lead-in study is to determine whether circulating tumor cells in patients with metastatic progressive castration-resistant prostate cancer or metastatic progressive breast cancer can be captured using a novel mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Progressive Castration-resistant Prostate Cancer, Metastatic Progressive Breast Cancer
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metastatic progressive castration-resistant prostate cancer
Arm Type
Other
Arm Description
Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
Arm Title
Metastatic progressive breast cancer
Arm Type
Other
Arm Description
Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
Intervention Type
Device
Intervention Name(s)
Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
Primary Outcome Measure Information:
Title
Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects, comparing the non-detection rate over time.
Time Frame
The change in non-detection rate will be measured by comparing samples from Screening, Cycle 3, and Progression (up to 3 years)
Secondary Outcome Measure Information:
Title
Comparison of the proportion of patients with no detectable CTCs between capture methods over time
Time Frame
Change will be measured by comparing samples at Screening, Cycle 3, Progression (up to 3 years)
Title
Changes in CTCs (using each method) over time during systemic therapy
Time Frame
Screening, Cycle 3, Progression (up to 3 years)
Title
Change in correlation of CTC enumeration using each method with baseline clinical and pathologic disease characteristics (for example, clinical stage, site of metastatic disease, Gleason sum for CRPC, PSA for CRPC, previous therapies)
Time Frame
Screening, Cycle 3, Progression (up to 3 years)
Title
Median number of CTCs detected by each method over time
Time Frame
Changes will be measured from screening, cycle 3 and progression (up to 3 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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).
Age > 18 years.
Ability to understand and the willingness to sign a written informed consent document.
Breast cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:
Histologically confirmed diagnosis of invasive breast cancer.
Clinical or radiographic evidence of metastatic disease.
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).
Age > 18 years.
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:
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 or mitoxantrone within 1 week of CTC collection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew J Armstrong, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method
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