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Isolation and Culture of Circulating Tumor Cells From Peripheral Blood

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2009 by BioCytics, Inc..
Recruitment status was:  Recruiting
Information provided by:
BioCytics, Inc. Identifier:
First received: December 10, 2007
Last updated: November 9, 2009
Last verified: November 2009

Primary Objective:

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

Metastatic Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study to Facilitate Development of an Ex Vivo Device Kit for Circulating Tumor Cell Harvesting, Banking, and Apoptosis-Viability Assay

Resource links provided by NLM:

Further study details as provided by BioCytics, Inc.:

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

Estimated Enrollment: 500
Study Start Date: November 2007
Estimated Study Completion Date: June 2012

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
  • 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.
  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 identifier: NCT00571389

Contact: Bryan Greene, Ph.D. 704-947-6599 ext 112
Contact: John Powderly, M.D. 704-947-6599

United States, North Carolina
Carolina BioOncology Institute Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Bryan Greene, Ph.D.    704-947-6599 ext 112   
Sponsors and Collaborators
BioCytics, Inc.
Principal Investigator: Bryan Greene, Ph.D. Carolina BioOncology Institute
  More Information

Additional Information:
Responsible Party: Dr. Bryan Greene, Chief Scientific Officer, BioCytics Identifier: NCT00571389     History of Changes
Other Study ID Numbers: Biocytics0001  WIRB Protocol # 20070969 
Study First Received: December 10, 2007
Last Updated: November 9, 2009

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Cells, Circulating
Neoplastic Processes
Pathologic Processes processed this record on February 24, 2017