ProstateNCT00026689
Evaluation for NCI Radiation Oncology Branch Clinical Research Protocols
An observational study of Prostate and Brain, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: -This protocol will provide a means for screening potential candidates for NCI Radiation Oncology Branch (ROB) protocols. Objectives: -To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology… Read more about this study
- Who is it for?
- Ages Up to 90 years
- How many people
- 903 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2000to 25 Feb 2019
- 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 Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment.
- Patient or guardian is able to provide informed consent.
Who cannot join
- Candidates who do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
-This protocol will provide a means for screening potential candidates for NCI Radiation Oncology Branch (ROB) protocols.
Objectives:
-To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols.
Eligibility:
-Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment.
Design:
-This is a screening protocol. No investigational treatments will be administered on this protocol.
Read the detailed description
Background:
-This protocol will provide a means for screening potential candidates for NCI Radiation Oncology Branch (ROB) protocols.
Objectives:
-To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols.
Eligibility:
-Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment.
Design:
-This is a screening protocol. No investigational treatments will be administered on this protocol.
- Conditions
- Prostate, Brain, Breast, Lung, Endometrial
- Keywords
- Evaluation, Screening, Cancer, Radiation, Eligibility
- Medical subject headings
- 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 |
|---|---|---|
| 1/Cohort 1 | Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols.
Evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols.
Measured: Completion of study
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 start11 Sep 2000
- Study completion25 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstateStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 903 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kevin A Camphausen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00026689
- Sponsor's protocol ID
- 000181
- Other IDs
- 00-C-0181
- Status last verified
- 25 Feb 2019
- First submitted
- 14 Nov 2001
- Last updated
- 12 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation for NCI Radiation Oncology Branch Clinical Research Protocols
- ClinicalTrials.gov ID
- NCT00026689
- Acronym / sponsor ID
- 000181
- Conditions
- Prostate, Brain, Breast, Lung, Endometrial
- Keywords
- Evaluation, Screening, Cancer, Radiation, Eligibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 903 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 11 Sep 2000
- Study completion
- 25 Feb 2019
- 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.
Background:
-This protocol will provide a means for screening potential candidates for NCI Radiation Oncology Branch (ROB) protocols.
Objectives:
-To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols.
Eligibility:
-Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment.
Design:
-This is a screening protocol. No investigational treatments will be administered on this protocol.
Detailed description
Background:
-This protocol will provide a means for screening potential candidates for NCI Radiation Oncology Branch (ROB) protocols.
Objectives:
-To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols.
Eligibility:
-Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment.
Design:
-This is a screening protocol. No investigational treatments will be administered on this protocol.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Cohort 1 | – | –Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment |
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment.
- Patient or guardian is able to provide informed consent.
Key exclusion criteria (1 listed)
- Candidates who do not meet the inclusion criteria.
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
To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols.
Time frame: Completion of study
Evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical 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 12 Dec 2019.
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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.
Kevin A Camphausen, 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 Prostate and Brain, 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 12 Dec 2019. 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?
To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols. (time frame: Completion of study). 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 12 Dec 2019.