Male Breast Cancer Summa Health System/Akron City Hospita... | NCT00773669

Studies
Male Breast Cancer Summa Health System/Akron City Hospital Experience 1995-2007

NCT00773669

Sponsor

Summa Health System

Status

Completed

Last Update Posted

May 31, 2013Estimated

Enrollment

24Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Mar 2011Actual

Completion Date

Dec 2012Actual

First Submitted Date

Oct 15, 2008

First Submission Date that Met QC Criteria

Oct 15, 2008

First Posted Date

Oct 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2013

Last Update Posted Date

May 31, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.
document treatment modalities and outcomes.
analyze outcomes for comparison to historical data.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		Chart review from 1995-2007

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male breast cancer patients diagnosed and/or treated at Summa Health System/Akron City Hospital from the reference year of 1995 through 2007.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Males with breast cancer.

Sampling Method

Probability Sample

Name	Affiliation	Role
Gary Williams, MD	Summa Health System	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D018567	Breast Neoplasms, Male

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided