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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Duke University
Sponsor:
Collaborators:
Prostate Cancer Foundation
Janssen Diagnostics, LLC
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02080650
First received: March 3, 2014
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Prostate Cancer
Renal Cell Carcinoma
Bladder Cancer
Colorectal Cancer
Gastric Cancer
Pancreatic Cancer
Device: Mesenchymal-marker based ferrofluid (c-MET)
Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Characterization of Circulating Tumor Cells Captured by c-MET (CTC-MET)

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Feasibility [ Time Frame: Only 1 sample will be obtained at a regular clinic visit. ] [ Designated as safety issue: No ]
    Feasibility as measured by successfully detecting at least one CTC in at least 2 out of 10 subjects within each disease site.


Secondary Outcome Measures:
  • Difference in the median number of CTCs [ Time Frame: Only 1 sample will be obtained at a regular clinic visit. ] [ Designated as safety issue: No ]
    The difference in the median number of CTCs detected by each of the capture methods (novel and standard) will be calculated.

  • Association of the number of detectable CTCs with baseline clinical and pathologic disease characteristics. [ Time Frame: Only 1 sample will be obtained at a regular clinic visit. ] [ Designated as safety issue: No ]
    Within each method, the patient will be used as the unit of observation to describe the association of number of detectable CTC cells with the following baseline characteristics: TNM staging, site of metastases (e.g., bone, liver, lymph nodes), Gleason sum (for PC), PSA (for PC), the number of prior hormone therapies (in PC), CEA (for colorectal cancer), the use of previous EGFR inhibitors and KRAS mutation status (for colorectal cancer), HER2 status and prior HER2 treatments (for gastric cancer), CA 19-9 (for pancreatic cancer), and number of prior chemotherapies.


Estimated Enrollment: 60
Study Start Date: March 2014
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Prostate cancer
Mesenchymal-marker based ferrofluid (c-MET)
Device: Mesenchymal-marker based ferrofluid (c-MET) Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid
Renal cell carcinoma
Mesenchymal-marker based ferrofluid (c-MET)
Device: Mesenchymal-marker based ferrofluid (c-MET) Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid
Bladder cancer
Mesenchymal-marker based ferrofluid (c-MET)
Device: Mesenchymal-marker based ferrofluid (c-MET) Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid
Gastric cancer
Mesenchymal-marker based ferrofluid (c-MET)
Device: Mesenchymal-marker based ferrofluid (c-MET) Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid
Colorectal cancer
Mesenchymal-marker based ferrofluid (c-MET)
Device: Mesenchymal-marker based ferrofluid (c-MET) Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid
Pancreatic cancer
Mesenchymal-marker based ferrofluid (c-MET)
Device: Mesenchymal-marker based ferrofluid (c-MET) Device: Epithelial cell adhesion molecule (EpCAM) ferrofluid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. Enrollment prior to the initiation of a new systemic therapy.
  5. 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).
  6. Age > 18 years.
  7. Ability to understand and the willingness to sign a written informed consent document.

Renal cell carcinoma patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:

  1. Histologically confirmed diagnosis of invasive renal cell carcinoma (all histologies)
  2. Clinical or radiographic evidence of metastatic disease.
  3. Evidence of disease progression on the current or following the most recent therapy, as evidenced by radiographic evidence of disease progression as defined by a new soft tissue/visceral metastatic lesion.
  4. For clear cell carcinoma, refractory to treatment with VEGF inhibitors as defined by progression on VEGF therapy within 1 year of starting VEGF therapy. For non-clear cell histologies, any line of systemic therapy.
  5. Enrollment prior to the initiation of a new systemic therapy.
  6. Age > 18 years.
  7. Ability to understand and the willingness to sign a written informed consent document.

Bladder 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 bladder transitional cell carcinoma, adenocarcinoma, squamous cell carcinoma, or small cell carcinoma.
  2. Metastatic disease with either bone or visceral metastatic lesions, or clinically symptomatic with metastatic disease.
  3. Progression with a new metastatic lesion.
  4. Enrollment prior to the initiation of a new systemic therapy.
  5. Age > 18 years.
  6. Ability to understand and the willingness to sign a written informed consent document.

Gastric cancer (including gastroesophageal junction) patients will be eligible for inclusion in this study only if all of the following inclusion criteria apply:

  1. Histologically confirmed diagnosis of invasive gastric adenocarcinoma.
  2. Clinical or radiographic evidence of metastatic disease.
  3. Enrollment prior to the initiation of a new systemic therapy.
  4. Age > 18 years.
  5. Ability to understand and the willingness to sign a written informed consent document.

Colorectal 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 colorectal adenocarcinoma.
  2. Clinical or radiographic evidence of metastatic disease.
  3. Evidence of disease progression on the current or following the most recent therapy, as evidenced by radiographic evidence of disease progression as defined by new soft tissue/visceral metastases >1 cm in diameter (2 cm for lymph nodes).
  4. Enrollment prior to the initiation of a new systemic therapy.
  5. Age > 18 years.
  6. Ability to understand and the willingness to sign a written informed consent document.

Pancreatic 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 pancreatic adenocarcinoma.
  2. Clinical or radiographic evidence of metastatic disease.
  3. Enrollment prior to the initiation of a new systemic therapy.
  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 (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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02080650

Contacts
Contact: Tian Zhang, MD (919) 970-3423 tian.zhang2@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Tian Zhang, MD    919-970-3423    tian.zhang2@duke.edu   
Principal Investigator: Andrew J Armstrong, MD         
Sponsors and Collaborators
Duke University
Prostate Cancer Foundation
Janssen Diagnostics, LLC
Investigators
Principal Investigator: Andrew J Armstrong, MD Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02080650     History of Changes
Other Study ID Numbers: Pro00052149
Study First Received: March 3, 2014
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Colorectal Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Prostatic Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasm Metastasis
Endocrine Gland Neoplasms
Pancreatic Diseases
Genital Neoplasms, Male
Carcinoma
Carcinoma, Renal Cell
Neoplastic Cells, Circulating
Urinary Bladder Diseases
Urologic Diseases
Adenocarcinoma
Kidney Diseases
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 26, 2014