Brief Summary

RATIONALE: Gathering information about patients with breast cancer and their families may help the study of breast cancer in the future. PURPOSE: This clinical trial is gathering information about patients with breast cancer and their families.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

4,945

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2006

Longer than P75 for all trials

Geographic Reach

1 country

65 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.9 years study duration

Study Start

First participant enrolled

October 12, 2006

Completed

1.5 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2008

Completed

8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2016

Completed

Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

9.9 years

First QC Date

April 24, 2008

Last Update Submit

October 7, 2023

Conditions

Breast Cancer Precancerous Condition

Keywords

male breast cancerbreast cancerductal breast carcinoma in situlobular breast carcinoma in situatypical ductal breast hyperplasia

Outcome Measures

Primary Outcomes (3)

Implementation of a web-based Breast Cancer Collaborative Registry at the National Comprehensive Cancer Network (NCCN) centers
Web-based registry
Ongoing
Merger of data collected under the Adult Oncology Data Collection Study and the National Comprehensive Cancer Network Data Coordinating study at UNMC/NMC
Web-based registries.
Ongoing
Standardization of clinical, environmental, socio-demographic, and family history data collected for breast cancer-related research and shared by the Eppley Breast Cancer Research Group collaborators
Web-based registry.
Ongoing

Interventions

medical chart reviewOTHER

Demographic information (like address and birth date), the results of physical exams, blood tests, x-rays and other diagnostic and medical procedures and treatments, as well as medical and surgical history.

questionnaire administrationOTHER

Collection of personal information, medical history, diet and lifestyle habits, any past or current environmental exposures and to re-create a family tree for any cancers that have occurred in any family members. In accordance with OPRR guidelines, no identifying information such as name, address, or date of birth will be used for relatives, but the affected status (cancer, age of onset, year of birth, age of death) will be recorded.

study of socioeconomic and demographic variablesOTHER

Repository

Excess human biological tissuePROCEDURE

Tissue procurement.

quality-of-life assessmentPROCEDURE

Cancer care.

Eligibility Criteria

Age19 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

1. Adult individuals (male and female) who have a personal diagnosis/history of breast cancer, atypical hyperplasia, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) (as stated in the NCCN Breast and/or Ovarian Genetic Assessment Guidelines v.1.2006 (Appendix A) 2. Adult individuals who have characteristics of hereditary breast cancer, as defined in the NCCN Breast and/or Ovarian Genetic Assessment Guidelines v.1.2006 (Appendix A) or who have a breast cancer risk of \> 1.67% over 5 years as estimated by GAIL Model (Appendix C ) 3. Age 19 or greater 4. Able to provide informed consent

You may qualify if:

Current diagnosis or history of breast cancer
Atypical hyperplasia
Ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) as defined in the National Comprehensive Cancer Network Breast and/or Ovarian Genetic Assessment Guidelines, v.1.2006
Characteristics of hereditary breast cancer, as defined in the National Comprehensive Cancer Network Breast and/or Ovarian Genetic Assessment Guidelines, v.1.2006 (relatives have been diagnosed with breast and/or ovarian cancer) OR have a breast cancer risk of \> 1.67% over 5 years as estimated by the GAIL Model

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Nebraskalead
National Cancer Institute (NCI)collaborator

Study Sites (65)

Penrose Cancer Center

Colorado Springs, Colorado, 80907, United States

Location

Centura - Porter Adventist Hospital

Denver, Colorado, 80210, United States

Location

Centura - St. Anthony Hospital

Lakewood, Colorado, 80228, United States

Location

Centura - Parker Adventist Hospital

Parker, Colorado, 80138, United States

Location

Centura - St. Mary Corwin Medical Center

Pueblo, Colorado, 81004, United States

Location

Halifax Health Medical Center

Daytona Beach, Florida, 32114, United States

Location

Florida Hospital Memorial Medical Center

Daytona Beach, Florida, 32117, United States

Location

Hlaifax Health Medical Center

Daytona Beach, Florida, 32127, United States

Location

Florida Hospital Deland

DeLand, Florida, 32720, United States

Location

Florida Hospital FISH

Orange City, Florida, 32763, United States

Location

Halifax Health Medical Center

Ormond Beach, Florida, 32174, United States

Location

Florida Hospital Flagler

Palm Coast, Florida, 32164, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60504, United States

Location

Trinity Medical Center

Moline, Illinois, 61265, United States

Location

Rush-Copley Healthcare Center

Yorkville, Illinois, 60560, United States

Location

Community Cancer Care

Anderson, Indiana, 46011, United States

Location

Community Clinical Research Center

Anderson, Indiana, 46011, United States

Location

Community Hospital of Anderson and Madison County, Inc

Anderson, Indiana, 46011, United States

Location

Community Health Network

Indianapolis, Indiana, 46219, United States

Location

Community Cancer Center South

Indianapolis, Indiana, 46227, United States

Location

Community Cancer Center North

Indianapolis, Indiana, 46256, United States

Location

Methodist Jennie Edmundson Hospital

Council Bluffs, Iowa, 51503, United States

Location

Genesis Medical Center

Davenport, Iowa, 52804, United States

Location

Iowa Cancer Specialists

Davenport, Iowa, 52804, United States

Location

Mercy Medical Center, North Iowa

Mason City, Iowa, 50401, United States

Location

Abben Cancer Center

Spencer, Iowa, 51301, United States

Location

Covenant Medical Center, Inc

Waterloo, Iowa, 50702, United States

Location

Saint Luke's Cancer Instititue, South

Overland Park, Kansas, 66213, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Central Maine Medical Center, Bennett Breast Care Center