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Isolation and Culture of Immune Cells and Circulating Tumor Cells From Peripheral Blood and Leukapheresis Products

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ClinicalTrials.gov Identifier: NCT00571389
Recruitment Status : Recruiting
First Posted : December 12, 2007
Last Update Posted : September 10, 2020
Sponsor:
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
Solid Tumor, Adult Healthy Donors COVID-19 Donors

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Study Type : Observational
Estimated Enrollment : 1000 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 : February 2025
Estimated Study Completion Date : February 2025



Biospecimen Retention:   Samples With DNA
Peripheral whole blood, immune cells, circulating tumor cells, discarded tissue obtained from biopsies and fluid (paracentesis, pleuracentesis), plasma-leukapheresis products, saliva, urine and stool.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 solid tumors of any stage, 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 prospective study.

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

Criteria

Inclusion Criteria for Biospecimen(s) collection:

  • Histological diagnosis of metastatic stage IV or locally advanced (unresectable) stage III cancer of any solid tumor type, histological non-metastatic cancer of any solid tumor type of any stage and healthy volunteers
  • Age ≥ 18yo
  • Life expectancy ≥ 12 weeks
  • ECOG Performance Status of 0, 1, 2, or 3 (Appendix 2)
  • Negative serology screening test for HIV, HBV and HCV; in event of a postive result, a reflex PCR may be performed and if negative, the pt may be allowed on the study

Additional Subject Eligibility for Leukapheresis Collection:

  • ECOG Performance Status of 0 or 1
  • Screening laboratory values must meet following criteria on leukapheresis collection day:

    • WBC ≥ 2000/µL
    • Neutrophils ≥ 1500/µL
    • Platelets ≥ 100 x103/µL
    • Hemoglobin ≥ 9 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:

  • Patients with any active infection requiring therapy (fever, localizing source) will be excluded until the infection resolves.
  • Confirmed PCR test result for HIV, HBV or HCV
  • 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 ClinicalTrials.gov identifier (NCT number): NCT00571389


Contacts
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Contact: John Powderly, MD 704-947-6599 jpowderly@carolinabiooncology.org

Locations
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United States, North Carolina
Carolina BioOncology Institute Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Rochelle Emery, MD, CCRC    704-947-6599 ext 1147    remery@carolinabiooncology.org   
Sub-Investigator: Rochelle Emery, MD         
Sponsors and Collaborators
BioCytics, Inc.
Investigators
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Principal Investigator: John Powderly, MD Carolina BioOncology Institute
Additional Information:
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Responsible Party: BioCytics, Inc.
ClinicalTrials.gov Identifier: NCT00571389    
Other Study ID Numbers: BioCytics 0001
WIRB Protocol # 20070969
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Keywords provided by BioCytics, Inc.:
All Stages of cancer
All stages of solid tumor origin
Additional relevant MeSH terms:
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Neoplastic Cells, Circulating
Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes