Isolation and Culture of Circulating Tumor Cells From Peripheral Blood

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by BioCytics, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
BioCytics, Inc.
ClinicalTrials.gov Identifier:
NCT00571389
First received: December 10, 2007
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

Primary Objective:

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


Condition
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
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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 ClinicalTrials.gov identifier: NCT00571389

Contacts
Contact: Bryan Greene, Ph.D. 704-947-6599 ext 112 bryan.greene@carolinabiooncology.org
Contact: John Powderly, M.D. 704-947-6599 john.powderly@carolinabiooncology.org

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

Additional Information:
No publications provided

Responsible Party: Dr. Bryan Greene, Chief Scientific Officer, BioCytics
ClinicalTrials.gov Identifier: NCT00571389     History of Changes
Other Study ID Numbers: Biocytics0001, WIRB Protocol # 20070969
Study First Received: December 10, 2007
Last Updated: November 9, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014