RECRUITING

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

Conditions

Solid Tumor, Adult Healthy Donors COVID-19 Donors All Stages of cancer All stages of solid tumor origin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2007-11

Study Completion:2025-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT00571389

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or Female Adult ≥ 18 years of age. 2. Histological diagnosis of any solid tumor type and at any stage of disease progression including in the neoadjuvant/presurgical setting, adjuvant setting, or considered in remission. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 3 (see Appendix 2) and an estimated life expectancy of at least 3 months. 4. Subject or subject's legal representative provides written informed consent. 5. Negative serology screening test for HIV, Hepatitis B surface antigen, and Hepatitis C antibody, or negative reflex PCR test result for HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) 6. Additional eligibility criteria need to be met for leukapheresis collection: * ECOG Performance Status of 0 or 1 (see Appendix 2) * WBC ≥2000/μL * Neutrophils ≥1000/μL * Platelets ≥100x103/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) * Negative urine pregnancy test for women of childbearing potential	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. Male or Female Adult ≥ 18 years of age.
2. Histological diagnosis of any solid tumor type and at any stage of disease progression including in the neoadjuvant/presurgical setting, adjuvant setting, or considered in remission.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 3 (see Appendix 2) and an estimated life expectancy of at least 3 months.
4. Subject or subject's legal representative provides written informed consent.
5. Negative serology screening test for HIV, Hepatitis B surface antigen, and Hepatitis C antibody, or negative reflex PCR test result for HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
6. Additional eligibility criteria need to be met for leukapheresis collection:
* ECOG Performance Status of 0 or 1 (see Appendix 2)
* WBC ≥2000/μL
* Neutrophils ≥1000/μL
* Platelets ≥100x103/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)
* Negative urine pregnancy test for women of childbearing potential

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

John Powderly, MD

CONTACT

704-947-6599

jpowderly@carolinabiooncology.org

Principal Investigator

John Powderly, MD

PRINCIPAL_INVESTIGATOR

Carolina BioOncology Institute

Study Locations (Sites)

Carolina BioOncology Institute

Huntersville, North Carolina, 28078

United States

Collaborators and Investigators

Sponsor: BioCytics, Inc.

John Powderly, MD, PRINCIPAL_INVESTIGATOR, Carolina BioOncology Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2007-11

Study Completion Date2025-02

Study Record Updates

Study Start Date2007-11

Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

All Stages of cancer
All stages of solid tumor origin

Additional Relevant MeSH Terms

Solid Tumor, Adult
Healthy Donors
COVID-19 Donors