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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by BioCytics, Inc.
Sponsor:
Collaborator:
Carolina BioOncology Institute
Information provided by (Responsible Party):
BioCytics, Inc.
ClinicalTrials.gov Identifier:
NCT00571389
First received: December 10, 2007
Last updated: March 24, 2017
Last verified: March 2017
  Purpose

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
Metastatic Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by BioCytics, Inc.:

Biospecimen Retention:   Samples With DNA
Blood cells, tumor cells, immune 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: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
  Eligibility

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

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 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.
  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: John Powderly, M.D. 704-947-6599 jpowderly@carolinabiooncology.org

Locations
United States, North Carolina
Carolina BioOncology Institute Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Katie Gradert, BS    704-947-6599    kgradert@carolinabiooncology.org   
Sponsors and Collaborators
BioCytics, Inc.
Carolina BioOncology Institute
Investigators
Principal Investigator: John Powderly, M.D. Carolina BioOncology Institute
  More Information

Additional Information:
Responsible Party: BioCytics, Inc.
ClinicalTrials.gov Identifier: NCT00571389     History of Changes
Other Study ID Numbers: Biocytics0001
WIRB Protocol # 20070969
Study First Received: December 10, 2007
Last Updated: March 24, 2017

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 April 21, 2017