Solid Tumor, AdultNCT00571389
A Biospecimen Collection Study of Leukapheresis-Derived Circulating Tumor Cells, Immune Cells, and Progenitor Cells.
An observational study of Solid Tumor, Adult and Healthy Donors, run by BioCytics, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor, Adult, Healthy Donors, COVID-19 Donors
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Cancer Cohort Inclusion Criteria:
- Male or Female Adult ≥ 18 years of age.
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 3 (see Appendix 2) and an estimated life expectancy of at least 3 months.
- Subject or subject's legal representative provides written informed consent.
- 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)
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- 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:
- 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.
- 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.
- Subject or subject's legal representative provides written informed consent.
- 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.
- 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
- Subjects with active infection requiring therapy (fever, localizing source) will be excluded until the infection resolves.
- This excludes subjects with suspected or confirmed COVID-19 by laboratory test while in the acute and sub-acute phase of viremia.
- Underlying medical condition that, in the Principal Investigator's or treating oncologist's opinion, will obscure the interpretation of the patient's safety.
- Confirmed positive reflex PCR test result for HIV, Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
John Powderly, MD contact
United States1 site, 1 recruiting
- Recruiting
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Camila Vedia, MS, 7049476599 ext. 1149, cvedia@biocytics.com
Ashley Wallace, 7049476599
About this study
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.
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.
- Conditions
- Solid Tumor, Adult, Healthy Donors, COVID-19 Donors
- Keywords
- All Stages of cancer, All stages of solid tumor origin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioCytics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571389
- Sponsor's protocol ID
- BioCytics 0001
- Other IDs
- WIRB Protocol # 20070969
- Status last verified
- Mar 2026
- First submitted
- 10 Dec 2007
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00571389
- Acronym / sponsor ID
- BioCytics 0001
- Conditions
- Solid Tumor, Adult, Healthy Donors, COVID-19 Donors
- Keywords
- All Stages of cancer, All stages of solid tumor origin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- BioCytics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (40 listed)
- Male or Female Adult ≥ 18 years of age.
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 3 (see Appendix 2) and an estimated life expectancy of at least 3 months.
- Subject or subject's legal representative provides written informed consent.
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Related InfoLink provided by the sponsor.
- Sister-company website; A Phase I Clinical Trial SiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Powderly, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, Adult and Healthy Donors, run by BioCytics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 40 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Powderly, MD (704-947-6599), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.