Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)

Duke University1 site in 1 country62 target enrollmentMarch 2014

ConditionsProstate Cancer Renal Cell Carcinoma Bladder Cancer Colorectal Cancer Gastric Cancer Pancreatic Cancer Non-small Cell Lung Cancer Advanced MET Amplified Solid Tumor

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Duke University
Enrollment: 62
Locations: 1
Primary Endpoint: Feasibility
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This pilot study will aim to determine whether circulating tumor cells (CTCs) can be captured using the novel cMET based ferrofluid. The primary objective of this pilot study will be to describe the numbers of c-MET expressing cells that can be detected by the c-MET CTC capture technique. These data will be separated by disease site. The investigator will also describe the detection rates of both the c-MET CTC capture and the EpCAM CTC capture techniques in each patient, also separated by disease site.

Registry

clinicaltrials.gov

Start Date

March 2014

End Date

July 19, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Duke University

Responsible Party

Sponsor

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)
•Enrollment prior to the initiation of a new systemic therapy.
•Evidence of disease progression on or following most recent therapy as evidenced by either of the following:
•Two consecutive PSA levels greater than the PSA nadir achieved on ADT and most recent therapy, 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).
•Clinical progression of disease with cutaneous lesions or palpable lesions in absence of radiographic progression
•Age \> 18 years.

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 (including mitoxantrone, doxorubicin, epirubicin, and daunorubicin) within 1 week of CTC collection (applicable in prostate and gastric cancer patients), as anthracyclines cause auto-fluorescence of cells.

Outcomes

Primary Outcomes

Feasibility

Time Frame: day 1

Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects within each disease site.

Secondary Outcomes

Difference in the median number of CTCs(day 1)
Kinetics of CTCs over time during treatment with c-MET targeted therapies(8 weeks)
Association of the number of detectable CTCs with baseline clinical and pathologic disease characteristics.(day 1)