Cell FunctionNCT00342485
In Vitro Study of Peripheral Blood Mononuclear Cell Function in Healthy Individuals and Patients
An observational study of Cell Function, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Peripheral blood mononuclear cells (PBMC) will be collected from healthy volunteers and patients who present with different diseases that involve or implicate the immune system dysregulation (HIV infection, autoimmune diseases and cancer). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cell Function
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 1993to 3 Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Greater than or equal to 18 years old.
- Documented HIV infection by current DoD criteria (1 ELISA, 2 Confirmatory Western Blot) or by one of the following tests; DNA PCR, RNA PCR, p24 antigen test, viral culture assay.
- CD4 lymphocyte cell count greater than 300 mm(3).
Who cannot join
- Unable to provide informed consent.
- Unable to meet the minimum (150 days) and maximum (395 days) research visit interval requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Willford Hall USAF Medical Center
San Antonio, Texas, 78236
About this study
Peripheral blood mononuclear cells (PBMC) will be collected from healthy volunteers and patients who present with different diseases that involve or implicate the immune system dysregulation (HIV infection, autoimmune diseases and cancer). These PBMC will be studied in vitro for a number of functional parameters, including generating soluable factors that inhibit HIV infection, developing patterns of immune dysregulation, and inducing apoptotic T cell death. The purpose of such studies is to obtain insight into the mechanisms of natural resistance to viral infections, AIDS pathogenesis, and disease-induced immune dysregulation.
Read the detailed description
Peripheral blood mononuclear cells (PBMC) will be collected from healthy volunteers and patients who present with different diseases that involve or implicate the immune system dysregulation (HIV infection, autoimmune diseases and cancer). These PBMC will be studied in vitro for a number of functional parameters, including generating soluable factors that inhibit HIV infection, developing patterns of immune dysregulation, and inducing apoptotic T cell death. The purpose of such studies is to obtain insight into the mechanisms of natural resistance to viral infections, AIDS pathogenesis, and disease-induced immune dysregulation.
- Conditions
- Cell Function
- Keywords
- Cellular Immunity, HIV-infected, Immune Deficiency, Cancer, Transplantation
- Medical subject headings
- Immunologic Deficiency Syndromes, Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start12 Apr 1993
- Study completion3 Mar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cell FunctionStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Enrolment
- 5,000 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342485
- Sponsor's protocol ID
- 999993010
- Other IDs
- OH93-NC-N010
- Status last verified
- 3 Mar 2008
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Study of Peripheral Blood Mononuclear Cell Function in Healthy Individuals and Patients
- ClinicalTrials.gov ID
- NCT00342485
- Acronym / sponsor ID
- 999993010
- Conditions
- Cell Function
- Keywords
- Cellular Immunity, HIV-infected, Immune Deficiency, Cancer, Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 12 Apr 1993
- Study completion
- 3 Mar 2008
- First posted
- 21 Jun 2006 (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.
Peripheral blood mononuclear cells (PBMC) will be collected from healthy volunteers and patients who present with different diseases that involve or implicate the immune system dysregulation (HIV infection, autoimmune diseases and cancer). These PBMC will be studied in vitro for a number of functional parameters, including generating soluable factors that inhibit HIV infection, developing patterns of immune dysregulation, and inducing apoptotic T cell death. The purpose of such studies is to obtain insight into the mechanisms of natural resistance to viral infections, AIDS pathogenesis, and disease-induced immune dysregulation.
Detailed description
Peripheral blood mononuclear cells (PBMC) will be collected from healthy volunteers and patients who present with different diseases that involve or implicate the immune system dysregulation (HIV infection, autoimmune diseases and cancer). These PBMC will be studied in vitro for a number of functional parameters, including generating soluable factors that inhibit HIV infection, developing patterns of immune dysregulation, and inducing apoptotic T cell death. The purpose of such studies is to obtain insight into the mechanisms of natural resistance to viral infections, AIDS pathogenesis, and disease-induced immune dysregulation.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than or equal to 18 years old.
- Documented HIV infection by current DoD criteria (1 ELISA, 2 Confirmatory Western Blot) or by one of the following tests; DNA PCR, RNA PCR, p24 antigen test, viral culture assay.
- CD4 lymphocyte cell count greater than 300 mm(3).
Key exclusion criteria (2 listed)
- Unable to provide informed consent.
- Unable to meet the minimum (150 days) and maximum (395 days) research visit interval requirements.
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Cell Function, run by National Cancer Institute (NCI) 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 2 Jul 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 2 Jul 2017.