RecruitingNCT00571389

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

A Biospecimen Collection Study to Facilitate Development of an Ex-Vivo Device Platform for Culture, Immune Assay, and Biobanking of Leukapheresis-Derived Circulating Tumor Cells, Immune Cells, and Progenitor Cells.


Sponsor

BioCytics, Inc.

Enrollment

1,500 participants

Start Date

Nov 1, 2007

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This study collects blood and other biological samples (biospecimens) from cancer patients and healthy volunteers to help researchers study circulating tumor cells, immune cells, and stem-like cells. The goal is to better understand cancer biology and improve future treatments. Some participants may undergo a procedure called leukapheresis, which filters specific cells from your blood — similar to dialysis. You may be eligible if (Cancer patients): - You are 18 years of age or older - You have been diagnosed with any type of solid tumor at any stage - You have an adequate performance status and life expectancy of at least 3 months - You test negative for HIV, Hepatitis B, and Hepatitis C You may be eligible if (Healthy volunteers): - You are 18 or older (children aged 5–17 with suspected COVID-19 may qualify for limited, minimally invasive collection only) - You are generally healthy, including people with stable autoimmune conditions or COVID-19 - You test negative for HIV, Hepatitis B, and Hepatitis C You may NOT be eligible if: - You have an active infection currently requiring treatment (except COVID-19 in acute phase for leukapheresis exclusion) - You have a confirmed positive PCR test for HIV, Hepatitis B, or Hepatitis C - You have a medical condition that the investigator believes would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Carolina BioOncology Institute

Huntersville, North Carolina, United States

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NCT00571389


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