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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00571389
Recruitment Status : Recruiting
First Posted : December 12, 2007
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
BioCytics, Inc.

Brief 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.


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 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

Group/Cohort
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.
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.



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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years and older   (Child, 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 consist of two cohorts: 1) cancer patients, and to a lesser extent 2) healthy volunteers.
Criteria

Inclusion Criteria for Biospecimen(s) collection:

Cancer Cohort Inclusion 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

Healthy Volunteer Cohort Inclusion Criteria:

  1. Male or Female Adult ≥ 18 years of age.

    ▪ Pediatric healthy volunteers from 5-17 years of age, with suspected or confirmed COVID-19 diagnosis by laboratory test will be eligible to participate in minimally invasive biospecimen collection procedures, as long as written parental consent has been obtained, and if applicable and technologically able, child assent. Minimally invasive biospecimen collection procedures allowed for pediatric participation include swabs (nasal, NP and OP), microcapillary sampling, and saliva or urine collection.

  2. Healthy volunteers are eligible, including the following:

    • History of autoimmune disease or inflammatory disorder considered clinically stable by the Principal Investigator or treating physician's discretion.
    • Suspected or diagnosed COVID-19 disease by laboratory test, whether in the acute, sub-acute or convalesced state.
    • Employees of the study site(s) or BioCytics, as long as fulfilment of inclusion criteria 3.c is obtained.
  3. Subject or subject's legal representative provides written informed consent.
  4. Negative serology screening test for HIV, Hepatitis B surface antigen, and Hepatitis C antibody, or negative reflex PCR test result for HIV, HBV, and HCV.
  5. Additional eligibility criteria need to be met for leukapheresis collection:

    • Must be ≥ 18 years of age.
    • WBC ≥2000/μL
    • Neutrophils ≥1000/μL
    • Platelets ≥100x103/μL
    • Hemoglobin ≥9 g/dL
    • Creatinine ≤2.5 x ULN
    • AST ≤2.5 x ULN
    • 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

2.3.4. Exclusion Criteria

  1. Subjects with active infection requiring therapy (fever, localizing source) will be excluded until the infection resolves.

    a. This excludes subjects with suspected or confirmed COVID-19 by laboratory test while in the acute and sub-acute phase of viremia.

  2. Underlying medical condition that, in the Principal Investigator's or treating oncologist's opinion, will obscure the interpretation of the patient's safety.
  3. Confirmed positive reflex PCR test result for HIV, Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV).

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: Shruty Lakdawala, MD    704-947-6599 ext 1022    slakdawala@carolinabiooncology.org   
Contact: Camila Vedia, BS    704-947-6599 ext 1149    cvedia@carolinabiooncology.org   
Sub-Investigator: Shruty Lakdawala, MD         
Sponsors and Collaborators
BioCytics, Inc.
Investigators
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Principal Investigator: John Powderly, MD Carolina BioOncology Institute
  Study Documents (Full-Text)

Documents provided by BioCytics, Inc.:
Study Protocol  [PDF] December 8, 2020

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: April 27, 2022
Last Verified: April 2022
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