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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2030-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumor, Adult Healthy Donors COVID-19 Donors

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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

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.
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

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).

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes