Breast CancerNCT00026754
Eligibility Screening for the NIH Intramural Research Program Clinical Protocols
An observational study of Breast Cancer and Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
The purpose of this protocol is to provide patients with adequate informed consent to understand that screening tests with minimal health risk will be performed to evaluate their eligibility for a research study. Read more about this study
- Who is it for?
- Ages 1 month and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Prostate Cancer, Lung Cancer
- How many people
- 19,522 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2004to 29 Nov 2024
- 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 1 month and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients and healthy volunteers who are being evaluated for NIH Intramural Research Program (IRP) protocols must be screened to determine whether they meet the eligibility criteria prior to enrollment.
Who may be able to join
- Patients and healthy volunteers who are being evaluated for protocols within the NIH Intramural Research Program (IRP). Note: Participants must be > 1 month of age.
- All patients or their parent/guardians or Legally Authorized Representative (LAR) must sign a document of informed consent indicating their understanding of the research nature and the risks of the procedures that will be performed to assess eligibility for research protocols. NOTE: It is expected that healthy adult volunteers have the capacity to consent (i.e., a LAR may not be used).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
The purpose of this protocol is to provide patients with adequate informed consent to understand that screening tests with minimal health risk will be performed to evaluate their eligibility for a research study. The protocol makes it clear that patients initial visit to the intramural clinical program may include screening studies that are not medically necessary for disease management, but are done purely for research purposes.
Patients with a known or suspected diagnosis of cancer, HIV infection, skin disorder or immunodeficiency who are being considered for enrollment in a National Cancer Institute intramural clinical research protocol will participate in this consent protocol. It informs patients of screening tests and procedures involving minimal risk that are done for research purposes only, including blood tests, electrocardiogram, standard X-rays (e.g., chest X-ray), bone films, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine studies. It explains that other eligibility screens that are more invasive and involve greater risk, such as a biopsy, will require separate consent.
...
Read the detailed description
Background:
Patients and healthy volunteers who are being evaluated for NIH Intramural Research Program (IRP) protocols must be screened to determine whether they meet the eligibility criteria prior to enrollment.
Objectives:
Evaluate patient or healthy volunteer eligibility for participation in NIH IRP research protocols.
Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values.
Collect specific research samples required for the primary research protocol as part of a screening test or procedure in order to avoid from having to subject the patient to a painful procedure on multiple occasions.
Eligibility:
Patients and healthy volunteers who are being evaluated for and treated on protocols within the NIH IRP.
Design:
This protocol is not a research study of an investigational drug or device.
Screening tests and procedures that are required by the primary research protocols are conducted in order to establish eligibility for these protocols.
In some cases, specific research samples required for the primary research protocol may be collected during the screening process in order to avoid from having to subject the patient to a painful procedure on multiple occasions.
Tissues and biological fluids that are obtained during the screening process will be stored.
Once a patient or healthy volunteer completes the screening process and is either enrolled onto another NIH study or is returned to the care of their local physician they will be taken off study.
- Conditions
- Breast Cancer, Prostate Cancer, Lung Cancer, Sarcoma, Melanoma
- Keywords
- Screening, Cancer, HIV Infection, Scans, Laboratory Tests, HIV, Skin Disorders
- Medical subject headings
- Breast Neoplasms, Prostatic Neoplasms, Lung Neoplasms, Sarcoma, Melanoma, Neoplasms, HIV Infections, Skin Diseases
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 |
|---|---|---|
| Cohort 1 | Patients | |
| Cohort 2 | Healthy Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue for future research
Tissue remaining from collections during the screening process, either for research eligibility or as clinically indicated may be stored for future research
Measured: 10 years
Screening testing/results
Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values
Measured: 10 years
Research sample collection
Collect specific research samples required for the primary research protocol as part of a screening test or procedure in order to avoid from having to subject the patient to a painful procedure on multiple occasions
Measured: 10 years
Numbers of screened patients and healthy volunteers
Gather prospective information on the number of patients screened for a particular study and compare to those enrolled onto an interventional study or natural history study.
Measured: 10 years
Eligibility evaluations
Evaluate patient eligibility for participation in NCI/CCR research protocols
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2001 (estimated)
- Study start14 Jan 2004
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- 19,522 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- James L Gulley, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026754
- Sponsor's protocol ID
- 010129
- Other IDs
- 01-C-0129
- Status last verified
- Apr 2025
- First submitted
- 14 Nov 2001
- Last updated
- 18 Apr 2025
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eligibility Screening for the NIH Intramural Research Program Clinical Protocols
- ClinicalTrials.gov ID
- NCT00026754
- Acronym / sponsor ID
- 010129
- Conditions
- Breast Cancer, Prostate Cancer, Lung Cancer, Sarcoma, Melanoma
- Keywords
- Screening, Cancer, HIV Infection, Scans, Laboratory Tests, HIV, Skin Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,522 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 14 Jan 2004 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 15 Nov 2001 (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.
The purpose of this protocol is to provide patients with adequate informed consent to understand that screening tests with minimal health risk will be performed to evaluate their eligibility for a research study. The protocol makes it clear that patients initial visit to the intramural clinical program may include screening studies that are not medically necessary for disease management, but are done purely for research purposes.
Patients with a known or suspected diagnosis of cancer, HIV infection, skin disorder or immunodeficiency who are being considered for enrollment in a National Cancer Institute intramural clinical research protocol will participate in this consent protocol. It informs patients of screening tests and procedures involving minimal risk that are done for research purposes only, including blood tests, electrocardiogram, standard X-rays (e.g., chest X-ray), bone films, computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine studies. It explains that other eligibility screens that are more invasive and involve greater risk, such as a biopsy, will require separate consent.
...
Detailed description
Background:
Patients and healthy volunteers who are being evaluated for NIH Intramural Research Program (IRP) protocols must be screened to determine whether they meet the eligibility criteria prior to enrollment.
Objectives:
Evaluate patient or healthy volunteer eligibility for participation in NIH IRP research protocols.
Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values.
Collect specific research samples required for the primary research protocol as part of a screening test or procedure in order to avoid from having to subject the patient to a painful procedure on multiple occasions.
Eligibility:
Patients and healthy volunteers who are being evaluated for and treated on protocols within the NIH IRP.
Design:
This protocol is not a research study of an investigational drug or device.
Screening tests and procedures that are required by the primary research protocols are conducted in order to establish eligibility for these protocols.
In some cases, specific research samples required for the primary research protocol may be collected during the screening process in order to avoid from having to subject the patient to a painful procedure on multiple occasions.
Tissues and biological fluids that are obtained during the screening process will be stored.
Once a patient or healthy volunteer completes the screening process and is either enrolled onto another NIH study or is returned to the care of their local physician they will be taken off study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Patients |
| Cohort 2 | – | –Healthy Volunteers |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients and healthy volunteers who are being evaluated for NIH Intramural Research Program (IRP) protocols must be screened to determine whether they meet the eligibility criteria prior to enrollment.
Key inclusion criteria (2 listed)
- Patients and healthy volunteers who are being evaluated for protocols within the NIH Intramural Research Program (IRP). Note: Participants must be > 1 month of age.
- All patients or their parent/guardians or Legally Authorized Representative (LAR) must sign a document of informed consent indicating their understanding of the research nature and the risks of the procedures that will be performed to assess eligibility for research protocols. NOTE: It is expected that healthy adult volunteers have the capacity to consent (i.e., a LAR may not be used).
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
Tissue for future research
Time frame: 10 years
Tissue remaining from collections during the screening process, either for research eligibility or as clinically indicated may be stored for future research
Screening testing/results
Time frame: 10 years
Collect results of screening test for use on subsequent research protocols as baseline (e.g., pretreatment) values
Research sample collection
Time frame: 10 years
Collect specific research samples required for the primary research protocol as part of a screening test or procedure in order to avoid from having to subject the patient to a painful procedure on multiple occasions
Numbers of screened patients and healthy volunteers
Time frame: 10 years
Gather prospective information on the number of patients screened for a particular study and compare to those enrolled onto an interventional study or natural history study.
Eligibility evaluations
Time frame: 10 years
Evaluate patient eligibility for participation in NCI/CCR research protocols
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 18 Apr 2025.
- 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.
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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.
James L Gulley, M.D. 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 Breast Cancer and Prostate 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 2 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: finished, as of the sponsor's last update on 18 Apr 2025. 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.
What does the primary outcome measure?
Tissue for future research (time frame: 10 years). The study lists 5 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 18 Apr 2025.