Breast CancerPBI RegistryNCT01127971
Patient Registry: Partial Breast Irradiation
An observational study of Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is an Aurora Health Care system registry of patients receiving accelerated partial breast irradiation and external beam. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Sep 2013
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Aurora Health Care system patients receiving accelerated partial breast irradiation
Who may be able to join
- Aurora patients who decide to undergo PBI treatment in the next 5-years or who have had PBI Treatment in the last ten-years. All such patients are female.
Who cannot join
- Patients not seen in an Aurora facility
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
About this study
Official title: Patient Registry: A Study of the Use of Accelerated Partial Breast Irradiation to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities
This is an Aurora Health Care system registry of patients receiving accelerated partial breast irradiation and external beam.
- Conditions
- Breast Cancer
- Keywords
- patients, receiving, irradiation, device, External Beam
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates is collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates
The primary endpoint of this registry trial is collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates for each PBI type used and for the overall Aurora population. The following endpoints will also be reported and analyzed:
- Disease Free Survival
- Regional Recurrence
- Distant Metastasis
- Combined Recurrence
Measured: 5 and 10-year local recurrence rates
Secondary outcomes (1)
collection and analysis of data to evaluate and compare cosmetic outcome
The secondary endpoint is the collection and analysis of data to evaluate and compare cosmetic outcome (per Harvard Score) and toxicities/complications for each PBI type (per Common Terminology Criteria for Adverse Events (referred to as CTC or CTCAE))
Measured: 5 and 10-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startFeb 2010
- Primary completionSep 2013
- Study completionSep 2013
Why it stopped: administrative reasons (no impact/concern of subject rights, welfare, safety)
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Rohde, MD, Principal investigator, Aurora BayCare Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127971
- Sponsor's protocol ID
- L-04-147E
- Acronym
- PBI Registry
- Status last verified
- Oct 2014
- First submitted
- 20 May 2010
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Registry: A Study of the Use of Accelerated Partial Breast Irradiation to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities
- ClinicalTrials.gov ID
- NCT01127971
- Acronym / sponsor ID
- PBI Registry / L-04-147E
- Conditions
- Breast Cancer
- Keywords
- patients, receiving, irradiation, device, External Beam
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: administrative reasons (no impact/concern of subject rights, welfare, safety)
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 May 2010 (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 is an Aurora Health Care system registry of patients receiving accelerated partial breast irradiation and external beam.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Aurora Health Care system patients receiving accelerated partial breast irradiation
Key inclusion criteria (1 listed)
- Aurora patients who decide to undergo PBI treatment in the next 5-years or who have had PBI Treatment in the last ten-years. All such patients are female.
Key exclusion criteria (1 listed)
- Patients not seen in an Aurora facility
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
The collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates is collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates
Time frame: 5 and 10-year local recurrence rates
The primary endpoint of this registry trial is collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates for each PBI type used and for the overall Aurora population. The following endpoints will also be reported and analyzed: * Disease Free Survival * Regional Recurrence * Distant Metastasis * Combined Recurrence
1 secondary outcome
collection and analysis of data to evaluate and compare cosmetic outcome
Time frame: 5 and 10-year
Results and safety
The study was stopped early (reason given: administrative reasons (no impact/concern of subject rights, welfare, safety)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
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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.
David Rohde, MD principal investigator
Aurora BayCare Medical Center
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, run by Wake Forest University Health Sciences 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 1 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: stopped early, as of the sponsor's last update on 3 Oct 2024. 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 was stopped early (reason given: administrative reasons (no impact/concern of subject rights, welfare, safety)). Results are not available in the source record.
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?
The collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates is collection and analysis of sufficient data to determine 5 and 10-year local recurrence rates (time frame: 5 and 10-year local recurrence rates). 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 3 Oct 2024.