Prostate CancerNCT00034216
Collection of Blood From Patients With Cancer
An observational study of Prostate Cancer and Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. This study does not involve treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Breast Cancer, Colon Cancer
- How many people
- 1,750 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2002to not given
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary clinical; healthy volunteers may include NIH employees
Who may be able to join
- Patients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible.
- Performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.
- Ability to understand and the willingness to sign a written informed consent document.
- Note: Effective with Amendment CC, participants will no longer be asked to undergo apheresis. This content is being retained for historical reference.
- Hemoglobin greater than or equal to 10 mg/dL and platelet count > 75,000/mm(3)
- Weight greater than 25 kg
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- HIV negative
- Prothrombin Time - within normal limits
- Partial Thromboplastin Time - within normal limits
- Medically indicated central line in place or adequate peripheral venous access
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Cancer Institute Referral Office, 888-624-1937, ncimo_referrals@mail.nih.gov
About this study
Official title: Biospecimen Acquisition From Human Subjects
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. This study does not involve treatment.
Participants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their condition, patients may be invited to enroll in a clinical research study involving chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during the course of treatment.
...
Read the detailed description
Background:
- Correlative studies performed on biospecimens of human subjects can be used to investigate the biology of solid tumors, inform the development of new strategies for treating those cancers, and evaluate these new therapeutic approaches. Specific areas of interest include, but are not limited to:
- the underlying mechanisms of tumor-specific immune response and suppression in cancer patients
- genetic and molecular profiling of tumors through circulating tumor cell (cTC), circulating DNA, and tissue analysis
- investigation of potential early diagnostic and prognostic indicators for solid tumors such as cTCs and miRNA expression of serum exosomes
- identification of mechanisms of drug-related adverse events and correlation with clinical parameters
- the role of commensal gut microbiota in both the innate and adaptive responses to tumors as well as with the use of anticancer agents
Objectives:
- Analyze biospecimens such as tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
- Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
- Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Eligibility:
- Patients and healthy volunteers whose biospecimens are of interest to NIH investigators.
- 18 years of age or older.
Design:
- Cases will be evaluated by NCI or Interventional Radiology, NIH Clinical Center personnel. Blood, tissue, urine, saliva or other samples may be collected at the initial visit and at follow-up visits.
- Conditions
- Prostate Cancer, Breast Cancer, Colon Cancer, Lung Cancer, Liver Cancer
- Keywords
- Suppressor Cells, T-cells, CD4+ / CD25+ cells, Natural History, Cancer, Malignancy, Blood Sample
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms, Liver Neoplasms, Neoplasms
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 |
|---|---|---|
| Healthy Volunteers | Healthy volunteers 18 years of age and older | |
| Participants | Participants with cancer 18 years of age and older |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Measured: ongoing
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
Measured: ongoing
Collection of tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
Analyze tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2002 (estimated)
- Study start16 Jul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jennifer L Marte, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034216
- Sponsor's protocol ID
- 020179
- Other IDs
- 02-C-0179
- Status last verified
- 13 Oct 2026
- First submitted
- 24 Apr 2002
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biospecimen Acquisition From Human Subjects
- ClinicalTrials.gov ID
- NCT00034216
- Acronym / sponsor ID
- 020179
- Conditions
- Prostate Cancer, Breast Cancer, Colon Cancer, Lung Cancer, Liver Cancer
- Keywords
- Suppressor Cells, T-cells, CD4+ / CD25+ cells, Natural History, Cancer, Malignancy, Blood Sample
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,750 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 16 Jul 2002 (actual)
- First posted
- 24 Apr 2002 (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.
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. This study does not involve treatment.
Participants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their condition, patients may be invited to enroll in a clinical research study involving chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during the course of treatment.
...
Detailed description
Background:
- Correlative studies performed on biospecimens of human subjects can be used to investigate the biology of solid tumors, inform the development of new strategies for treating those cancers, and evaluate these new therapeutic approaches. Specific areas of interest include, but are not limited to:
- the underlying mechanisms of tumor-specific immune response and suppression in cancer patients
- genetic and molecular profiling of tumors through circulating tumor cell (cTC), circulating DNA, and tissue analysis
- investigation of potential early diagnostic and prognostic indicators for solid tumors such as cTCs and miRNA expression of serum exosomes
- identification of mechanisms of drug-related adverse events and correlation with clinical parameters
- the role of commensal gut microbiota in both the innate and adaptive responses to tumors as well as with the use of anticancer agents
Objectives:
- Analyze biospecimens such as tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
- Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
- Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Eligibility:
- Patients and healthy volunteers whose biospecimens are of interest to NIH investigators.
- 18 years of age or older.
Design:
- Cases will be evaluated by NCI or Interventional Radiology, NIH Clinical Center personnel. Blood, tissue, urine, saliva or other samples may be collected at the initial visit and at follow-up visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Healthy volunteers 18 years of age and older |
| Participants | – | –Participants with cancer 18 years of age and older |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary clinical; healthy volunteers may include NIH employees
Key inclusion criteria (10 listed)
- Patients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible.
- Performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.
- Ability to understand and the willingness to sign a written informed consent document.
- Note: Effective with Amendment CC, participants will no longer be asked to undergo apheresis. This content is being retained for historical reference.
- Hemoglobin greater than or equal to 10 mg/dL and platelet count > 75,000/mm(3)
Key exclusion criteria (1 listed)
- None.
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
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Time frame: ongoing
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
Time frame: ongoing
Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.
Collection of tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
Time frame: ongoing
Analyze tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects.
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 5 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request. @@@@@@All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
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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.
Jennifer L Marte principal investigator
National Cancer Institute (NCI)
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 Prostate Cancer and Breast Cancer, 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 10 inclusion and 1 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 5 Nov 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 Michell J Manu, R.N. ((240) 529-3415, michell.manu@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis. (time frame: ongoing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 5 Nov 2026.