A Biospecimen Collection Study of Leukapheresis-Derived Circulating Tumor Cells, Immune Cells, and Progenitor Cells.

Part of paid clinical trials in Huntersville, North Carolina.

Sponsor
BioCytics, Inc.
Study ID
NCT00571389
Status
Recruiting
Apply to this trial

Conditions

  • COVID-19 Donors
  • Healthy Donors
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
5 Years - N/A
Healthy Volunteers
Accepted

Study Details

Primary Objective: This is a study to investigate the feasibility of harvesting, expanding, and selecting T lymphocytes from cancer patients and healthy volunteers. The preliminary objective of this study is aimed at selecting PD-1+ and CTLA4+ T cells and other cellular fractions from peripheral blood of cancer patients and healthy volunteers by using specific conjugated antibodies, evaluating their functional ex vivo anti-tumor cytotoxicity against targeted autologous tumor cells.

Key Dates

Start date
Nov 30, 2007
Status verified
Mar 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
1,500 participants (estimated)

Arms

  • Arm: Cancer Cohort
    The first cohort 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.
  • Arm: Healthy Volunteer Cohort
    Healthy volunteers make up the second, smaller study population for this observational biospecimen laboratory study. Healthy volunteers serve primarily to aid in the proficiency, quality control and/or optimization of study procedures, experimental design assay development, and for device/equipment validation.
  • Arm: COVID-19 Disease Cohort
    Due to the COVID-19 pandemic and the consequent amendment to aid in the research response, study subjects with COVID-19 disease may participate in all aspects of this protocol, but depending on their disease state, infection timeline, and age, participation may be limited to only one component, procedure, and/or type of biospecimen collection. Age is a very important criteria, as pediatric subjects (5-17 years old) will only be eligible to participate in minimally invasive biospecimen collection procedures.

Central Contacts

  • John Powderly, MD
    704-947-6599

Locations (1)

FacilityCityStateZIPSite coordinators
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078
Camila Vedia, MS
[email protected]
7049476599
Ashley Wallace
7049476599
John Powderly, MD (PRINCIPAL_INVESTIGATOR)
Neel Gandhi, MD (SUB_INVESTIGATOR)
Sherene Banawan, PA-C (SUB_INVESTIGATOR)
Caroline Mastrosante, NP (SUB_INVESTIGATOR)

Find similar trials in Huntersville, NC

By research site
Carolina BioOncology Institute· Huntersville, NC

Related Studies