A Biospecimen Collection Study of Leukapheresis-Derived Circulating Tumor Cells, Immune Cells, and Progenitor Cells.
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|ClinicalTrials.gov Identifier: NCT00571389|
Recruitment Status : Recruiting
First Posted : December 12, 2007
Last Update Posted : April 27, 2022
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.
|Condition or disease|
|Solid Tumor, Adult Healthy Donors COVID-19 Donors|
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||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.|
|Study Start Date :||November 2007|
|Estimated Primary Completion Date :||February 2025|
|Estimated Study Completion Date :||February 2025|
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.
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.
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.
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
|Contact: John Powderly, MDfirstname.lastname@example.org|
|United States, North Carolina|
|Carolina BioOncology Institute||Recruiting|
|Huntersville, North Carolina, United States, 28078|
|Contact: Shruty Lakdawala, MD 704-947-6599 ext 1022 email@example.com|
|Contact: Camila Vedia, BS 704-947-6599 ext 1149 firstname.lastname@example.org|
|Sub-Investigator: Shruty Lakdawala, MD|
|Principal Investigator:||John Powderly, MD||Carolina BioOncology Institute|