Breast CancerNCT00773669
Male Breast Cancer Summa Health System/Akron City Hospital Experience 1995-2007
An observational study of Breast Cancer, run by Summa Health System.
Trial summary
The primary goal of this retrospective study is to evaluate the male breast cancer patient population at Summa Health System/Akron City Hospital over a period of 18 years and compare the findings to historical data. The objectives are to: identify risk factors. evaluate stage and histology at the time of presentation. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Breast Cancer
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Dec 2012
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Males with breast cancer.
Who may be able to join
- Male breast cancer patients diagnosed and/or treated at Summa Health System/Akron City Hospital from the reference year of 1995 through 2007.
Who cannot join
None listed.
About this study
The primary goal of this retrospective study is to evaluate the male breast cancer patient population at Summa Health System/Akron City Hospital over a period of 18 years and compare the findings to historical data.
The objectives are to:
- identify risk factors.
- evaluate stage and histology at the time of presentation.
- document treatment modalities and outcomes.
- analyze outcomes for comparison to historical data.
- Conditions
- Breast Cancer
- Keywords
- male breast cancer, Male breast cancer patients diagnosed and/or, treated at Summa Health System/Akron City Hospital, from the reference year of 1995 through 2007.
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective chart review to evaluate the male breast cancer patient population at Summa Health System/Akron City Hospital over a period of years and compare the findings to historical data.
Measured: Chart review from 1995-2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMar 2011
- Study completionDec 2012
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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Summa Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Williams, MD, Principal investigator, Summa Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773669
- Sponsor's protocol ID
- Male Breast Cancer
- Status last verified
- May 2013
- First submitted
- 15 Oct 2008
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Breast Cancer Summa Health System/Akron City Hospital Experience 1995-2007
- ClinicalTrials.gov ID
- NCT00773669
- Acronym / sponsor ID
- Male Breast Cancer
- Conditions
- Breast Cancer
- Keywords
- male breast cancer, Male breast cancer patients diagnosed and/or, treated at Summa Health System/Akron City Hospital, from the reference year of 1995 through 2007.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Summa Health SystemUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Oct 2008 (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 primary goal of this retrospective study is to evaluate the male breast cancer patient population at Summa Health System/Akron City Hospital over a period of 18 years and compare the findings to historical data.
The objectives are to:
- identify risk factors.
- evaluate stage and histology at the time of presentation.
- document treatment modalities and outcomes.
- analyze outcomes for comparison to historical data.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males with breast cancer.
Key inclusion criteria (1 listed)
- Male breast cancer patients diagnosed and/or treated at Summa Health System/Akron City Hospital from the reference year of 1995 through 2007.
Key exclusion criteria (0 listed)
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
Retrospective chart review to evaluate the male breast cancer patient population at Summa Health System/Akron City Hospital over a period of years and compare the findings to historical data.
Time frame: Chart review from 1995-2007
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 31 May 2013.
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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.
Gary Williams, MD principal investigator
Summa Health System
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Summa Health System.
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 0 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 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Retrospective chart review to evaluate the male breast cancer patient population at Summa Health System/Akron City Hospital over a period of years and compare the findings to historical data. (time frame: Chart review from 1995-2007). 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 31 May 2013.