Isolation and Culture of Immune Cells and Circulating Tumor Cells From Peripheral Blood and Leukopaks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00571389
Recruitment Status : Recruiting
First Posted : December 12, 2007
Last Update Posted : May 31, 2017
Carolina BioOncology Institute
Information provided by (Responsible Party):
BioCytics, Inc.

Brief Summary:

Primary Objective:

This is a study to investigate the feasibility of harvesting, expanding in culture, and freezing circulating tumor cells and immune cells from cancer patients and healthy volunteers.

Condition or disease
Metastatic Cancer

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Study to Facilitate Development of an Ex-Vivo Device Platform for Circulating Tumor Cell and Immune Cell Harvesting, Banking, and Apoptosis-Viability Assay
Study Start Date : November 2007
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Biospecimen Retention:   Samples With DNA
Blood cells, tumor cells, immune cells, plasma, discarded tissue (inc. tissue obtained from biopsies, paracentesis, pleuracentesis), leukapheresis products

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The population of patients to be enrolled for this study will be adults (males and females) with histological proven metastatic solid tumors seen for routine cancer care at participating community cancer clinic sites. Patients on clinical trials with experimental study drugs will be allowed to participate in this observational pilot study.

Healthy volunteers will also make up a portion of the study population


Inclusion Criteria:

  • Histological diagnosis of metastatic stage IV or locally advanced (unresectable) stage III cancer of any solid tumor type. Patients may have been previously treated or chemo naïve or healthy volunteer
  • Age > 18yo
  • Life expectancy > 12 weeks
  • ECOG Performance Status of 0, 1, 2, or 3 (Appendix 2)
  • Screening laboratory values must meet the following criteria:

    • WBC ≥2000/µL
    • Neutrophils ≥1500/µL
    • Platelets >100x103/µL
    • Hemoglobin ≥8 g/dL
    • Creatinine <2.5 x ULN
    • AST ≤2.5 x ULN without, and ≤ 5 x ULN with hepatic metastases
    • Bilirubin ≤2 x ULN (except patients with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL)

Exclusion Criteria:

  • Primary Hematologic Malignancies (leukemia, lymphoma)
  • Patients with any active infection requiring therapy (fever, localizing source) will be excluded until the infection resolves.
  • History of, or a positive test for HIV-1, HIV-2, or HTLV-1 serum antibody, hepatitis B surface antigen, or hepatitis C positive RNA
  • Underlying medical condition that, in the Principal Investigator's or treating oncologist's opinion, will obscure the interpretation of the patient's safety.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00571389

Contact: John Powderly, M.D. 704-947-6599

United States, North Carolina
Carolina BioOncology Institute Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Amanda Balasco, CCRC    704-947-6599   
Sponsors and Collaborators
BioCytics, Inc.
Carolina BioOncology Institute
Principal Investigator: John Powderly, M.D. Carolina BioOncology Institute

Additional Information:
Responsible Party: BioCytics, Inc. Identifier: NCT00571389     History of Changes
Other Study ID Numbers: Biocytics0001
WIRB Protocol # 20070969
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by BioCytics, Inc.:
Stage IV
Advanced Stage III

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Cells, Circulating
Neoplastic Processes
Pathologic Processes