Isolation of Circulating Tumor Cells Using a Novel EMT-Based Capture Method
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/22/2018 |
| Start Date: | November 2011 |
| End Date: | December 2015 |
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.
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.
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:
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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