Skip to main content
OpenTrials
Completed

NCT Number: NCT02025413

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Progressive Castration-resistant Prostate Cancer Metastatic Progressive Breast Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Janssen Diagnostics, LLC
  • Prostate Cancer Foundation
  • United States Department of Defense

Registry information

Acronym: CTC-EMT

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 1, 2014
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.