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CompletedNCT02025413CTC-EMTUpdated Dec 20, 2018

Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method

An interventional study of Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based) in Metastatic Progressive Castration-resistant Prostate Cancer and Metastatic Progressive Breast Cancer, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-20.

Sponsored by Duke University · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Metastatic Progressive Castration-resistant Prostate Cancer
  • Metastatic Progressive Breast Cancer
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In context

Neoplastic Cells, Circulating

240 studies on the registry are indexed under Neoplastic Cells, Circulating; 52 are open to participants now.

This study's enrollment of 46 is below the median of 76 across 95 interventional studies indexed under Neoplastic Cells, Circulating.

Browse Neoplastic Cells, Circulating studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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. 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.

Breast cancer patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:

  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

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 or mitoxantrone within 1 week of CTC collection
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Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • Other
    Metastatic progressive castration-resistant prostate cancer

    Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)

    Device: Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)

  • Other
    Metastatic progressive breast cancer

    Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)

    Device: Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)

Interventions

  • DeviceMesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)
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What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. Changes in CTCs (using each method) over time during systemic therapy

    Time frame: Screening, Cycle 3, Progression (up to 3 years)

  3. 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)

  4. 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)

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Study locations

1 site
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02025413
Lead sponsor
Duke University
Collaborators
Prostate Cancer Foundation, United States Department of Defense, Janssen Diagnostics, LLC
Responsible party
Sponsor
First posted
Jan 1, 2014
Start date
Nov 2011
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Dec 20, 2018

Study contacts

Andrew J Armstrong, MD
principal investigator · Duke University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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