Breast CancerBCCRNCT00666731
Breast Cancer Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer
An observational study of Breast Cancer and Precancerous Condition, run by University of Nebraska at 65 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 120 years
- Conditions the study is for
- Breast Cancer, Precancerous Condition
- What is being tested?
- medical chart review, questionnaire administration and study of socioeconomic and demographic variables
- Type of treatment
- Surgery or procedure
- How many people
- 4,945 participants
- Where
- 65 sitesUnited States
- Study dates
- 12 Oct 2006to 19 Aug 2016
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
United States65 sites
Avera Medical Group Oncology and Hematology Aberdeen
Aberdeen, South Dakota, 57401
Community Cancer Care
Anderson, Indiana, 46011
Community Clinical Research Center
Anderson, Indiana, 46011
Community Hospital of Anderson and Madison County, Inc
Anderson, Indiana, 46011
Rush-Copley Cancer Care Center
Aurora, Illinois, 60504
Wheaton Franciscan Healthcare - Elmbrook Memorial Hospital
Brookfield, Wisconsin, 53045
Penrose Cancer Center
Colorado Springs, Colorado, 80907
Methodist Jennie Edmundson Hospital
Council Bluffs, Iowa, 51503
Genesis Medical Center
Davenport, Iowa, 52804
Iowa Cancer Specialists
Davenport, Iowa, 52804
Halifax Health Medical Center
Daytona Beach, Florida, 32114
Florida Hospital Memorial Medical Center
Daytona Beach, Florida, 32117
Hlaifax Health Medical Center
Daytona Beach, Florida, 32127
Florida Hospital Deland
DeLand, Florida, 32720
Centura - Porter Adventist Hospital
Denver, Colorado, 80210
Cape Fear Valley Health System
Fayetteville, North Carolina, 28304
Wheaton Franciscan Healthcare - Reiman Cancer Care
Franklin, Wisconsin, 53132
C.R. Wood Cancer Center, Glens Falls Hospital
Glens Falls, New York, 12801
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742
Mary Lanning Healthcare/Morrison Cancer Center
Hastings, Nebraska, 68901
Holyoke Medical Center
Holyoke, Massachusetts, 01040
Community Health Network
Indianapolis, Indiana, 46219
Community Cancer Center South
Indianapolis, Indiana, 46227
Community Cancer Center North
Indianapolis, Indiana, 46256
Mercy Hospital - Joplin
Joplin, Missouri, 64804
Saint Luke's Cancer Institute - East
Kansas City, Missouri, 64086
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
Saint Luke's Cancer Institute - Kansas City North
Kansas City, Missouri, 64118
Good Samaritan Hospital/Cancer Center
Kearney, Nebraska, 68847
Centura - St. Anthony Hospital
Lakewood, Colorado, 80228
Central Maine Medical Center, Bennett Breast Care Center
Lewiston, Maine, 04240
Central Maine Medical Center, Cynthia A. Rydhom Cancer Treatment Center
Lewiston, Maine, 04240
Central Maine Medical Center, Hematology Oncology Associates
Lewiston, Maine, 04240
Central Maine Medical Center
Lewiston, Maine, 04240
Maine Research Associates
Lewiston, Maine, 04240
Saint Luke's Cancer Institute - Liberty
Liberty, Missouri, 64068
Mercy Medical Center, North Iowa
Mason City, Iowa, 50401
Trinity Hospital Cancer Care Center
Minot, North Dakota, 58701
Avera Cancer Institute
Mitchell, South Dakota, 57301
Trinity Medical Center
Moline, Illinois, 61265
Tulane University
New Orleans, Louisiana, 70112
Faith Regional Health Services, Carson Cancer Center
Norfolk, Nebraska, 68701
Great Plains Regional Medical Center
North Platte, Nebraska, 69101
UNMC Eppley Cancer Center, University of Nebraska Medical Center
Omaha, Nebraska, 68198-6805
Florida Hospital FISH
Orange City, Florida, 32763
Halifax Health Medical Center
Ormond Beach, Florida, 32174
Saint Luke's Cancer Instititue, South
Overland Park, Kansas, 66213
Florida Hospital Flagler
Palm Coast, Florida, 32164
Centura - Parker Adventist Hospital
Parker, Colorado, 80138
Beth Israel Deaconess Hospital
Plymouth, Massachusetts, 02360
Centura - St. Mary Corwin Medical Center
Pueblo, Colorado, 81004
Wheaton Franciscan Healthcare - All Saints
Racine, Wisconsin, 53405
Rutland Regional Medical Center
Rutland, Vermont, 05701
Heartland Regional Medical Center dba Mosaic Life Care
Saint Joseph, Missouri, 64506
Heartland Regional Medical Center dba Cancer Care, St. Joseph, Mosaic Life Care
Saint Joseph, Missouri, 64507
Regional West Health Services
Scottsbluff, Nebraska, 69361
Avera Cancer Center
Sioux Falls, South Dakota, 57105
Abben Cancer Center
Spencer, Iowa, 51301
Faxton St. Lukes (St. Elizabeth campus)
Utica, New York, 13501
Faxton St. Luke's Healthcare (Mohawk Valley Health Systems)
Utica, New York, 13502
Faxton St. Luke's Healthcare (St. Luke's Campus)
Utica, New York, 13502
Covenant Medical Center, Inc
Waterloo, Iowa, 50702
Wheaton Franciscan Healthcare - Wauwatosa Cancer Care
Wauwatosa, Wisconsin, 53226
William E Kahlert Regional Cancer Center
Westminster, Maryland, 21157
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560
About this study
Official title: Development and Implementation of The Breast Cancer Collaborative Registry (BCCR)
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.
Read the detailed description
OBJECTIVES:
- To develop a web-based Breast Cancer Collaborative Registry (BCCR) as a repository for socio-demographic, environmental, clinical history, family history, and biospecimen data collected at the National Comprehensive Cancer Network (NCCN) centers for participants with a personal history of breast cancer and/or characteristics of hereditary breast cancer.
- To merge the data already being collected on breast cancer patients under the Adult Oncology Data Collection Study and newly diagnosed breast cancer patients participating in the NCCN Data Coordinating study at UNMC/NMC.
- To standardize clinical, environmental, socio-demographic, and family history data for breast cancer-related information to be collected and shared for research purposes by Eppley Breast Cancer Research Group breast cancer research collaborators.
- To collect, validate, and disseminate the breast cancer-related data to establish a high-risk cohort for future research into the molecular and biological bases of breast cancer susceptibility and interventional trials.
OUTLINE: This is a multicenter study.
Study participants undergo data collection related to breast cancer studies at one of the National Comprehensive Cancer Network (NCCN) centers for inclusion in the Breast Cancer Collaborative Registry (BCCR). The BCCR is a comprehensive computerized database that serves as a repository for socio-demographic, environmental, clinical history, family history, and biospecimen data collected for breast cancer patients treated on UNMC protocols. Central features of the registry include standardized data-entry forms and a relational database that can be used as a resource for the study of the pathology, immunology, cytogenetics, molecular biology, epidemiology, clinical features, and outcome of patients with benign, pre-malignant, or malignant breast disease.
Study participants complete a self-administered electronic or paper-based survey and a medical history questionnaire at baseline to provide information on demographics (e.g., age and sex); personal and family medical history; treatment history; lifestyle, physical activity, and dietary habits; quality of life; environmental exposure history; and the family tree for inclusion in the registry. Participants also undergo telephone or in-person structured interviews conducted by study coordinators, genetic counselors, or the System Coordinator of the BCCR to provide additional information or clarification of the information provided in the questionnaires.
Study participants also undergo review of their medical records and pathology reports to obtain detailed medical and treatment-related information for inclusion in the registry. The information collected includes retrospective and prospective disease-specific data (e.g., diagnosis, grade/stage, and laboratory values) and longitudinal outcome data (e.g., response to treatment, toxicity, survival, relapse) derived during prospective clinical follow-up.
Study participants are followed periodically to update relevant health and family histories.
- Conditions
- Breast Cancer, Precancerous Condition
- Being tested
- medical chart review, questionnaire administration, study of socioeconomic and demographic variables, Excess human biological tissue, quality-of-life assessment
- Keywords
- male breast cancer, breast cancer, ductal breast carcinoma in situ, lobular breast carcinoma in situ, atypical ductal breast hyperplasia
- Medical subject headings
- Breast Neoplasms, Precancerous Conditions, Breast Neoplasms, Male, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
Tissue procurement.
quality-of-life assessmentProcedure or surgery
Cancer care.
What is being measured
The primary outcome is the main question the study is designed to answer.
Implementation of a web-based Breast Cancer Collaborative Registry at the National Comprehensive Cancer Network (NCCN) centers
Web-based registry
Measured: 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.
Measured: 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.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study start12 Oct 2006
- Primary completion19 Aug 2016
- Study completion19 Aug 2016
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.
- More trials run by University of NebraskaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 4,945 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kenneth H Cowan, MD, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666731
- Sponsor's protocol ID
- 0311-06-EP
- Other IDs
- P30CA036727
- Acronym
- BCCR
- Status last verified
- Oct 2023
- First submitted
- 24 Apr 2008
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of The Breast Cancer Collaborative Registry (BCCR)
- ClinicalTrials.gov ID
- NCT00666731
- Acronym / sponsor ID
- BCCR / 0311-06-EP
- Conditions
- Breast Cancer, Precancerous Condition
- Keywords
- male breast cancer, breast cancer, ductal breast carcinoma in situ, lobular breast carcinoma in situ, atypical ductal breast hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,945 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Oct 2006 (actual)
- Primary completion
- 19 Aug 2016 (actual)
- Study completion
- 19 Aug 2016 (actual)
- First posted
- 25 Apr 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.
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.
Detailed description
OBJECTIVES:
- To develop a web-based Breast Cancer Collaborative Registry (BCCR) as a repository for socio-demographic, environmental, clinical history, family history, and biospecimen data collected at the National Comprehensive Cancer Network (NCCN) centers for participants with a personal history of breast cancer and/or characteristics of hereditary breast cancer.
- To merge the data already being collected on breast cancer patients under the Adult Oncology Data Collection Study and newly diagnosed breast cancer patients participating in the NCCN Data Coordinating study at UNMC/NMC.
- To standardize clinical, environmental, socio-demographic, and family history data for breast cancer-related information to be collected and shared for research purposes by Eppley Breast Cancer Research Group breast cancer research collaborators.
- To collect, validate, and disseminate the breast cancer-related data to establish a high-risk cohort for future research into the molecular and biological bases of breast cancer susceptibility and interventional trials.
OUTLINE: This is a multicenter study.
Study participants undergo data collection related to breast cancer studies at one of the National Comprehensive Cancer Network (NCCN) centers for inclusion in the Breast Cancer Collaborative Registry (BCCR). The BCCR is a comprehensive computerized database that serves as a repository for socio-demographic, environmental, clinical history, family history, and biospecimen data collected for breast cancer patients treated on UNMC protocols. Central features of the registry include standardized data-entry forms and a relational database that can be used as a resource for the study of the pathology, immunology, cytogenetics, molecular biology, epidemiology, clinical features, and outcome of patients with benign, pre-malignant, or malignant breast disease.
Study participants complete a self-administered electronic or paper-based survey and a medical history questionnaire at baseline to provide information on demographics (e.g., age and sex); personal and family medical history; treatment history; lifestyle, physical activity, and dietary habits; quality of life; environmental exposure history; and the family tree for inclusion in the registry. Participants also undergo telephone or in-person structured interviews conducted by study coordinators, genetic counselors, or the System Coordinator of the BCCR to provide additional information or clarification of the information provided in the questionnaires.
Study participants also undergo review of their medical records and pathology reports to obtain detailed medical and treatment-related information for inclusion in the registry. The information collected includes retrospective and prospective disease-specific data (e.g., diagnosis, grade/stage, and laboratory values) and longitudinal outcome data (e.g., response to treatment, toxicity, survival, relapse) derived during prospective clinical follow-up.
Study participants are followed periodically to update relevant health and family histories.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical chart reviewDemographic 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. | Other | – |
| questionnaire administrationCollection 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. | Other | – |
| study of socioeconomic and demographic variablesRepository | Other | – |
| Excess human biological tissueTissue procurement. | Procedure or surgery | – |
| quality-of-life assessmentCancer care. | Procedure or surgery | – |
Primary outcome
Implementation of a web-based Breast Cancer Collaborative Registry at the National Comprehensive Cancer Network (NCCN) centers
Time frame: Ongoing
Web-based registry
Merger of data collected under the Adult Oncology Data Collection Study and the National Comprehensive Cancer Network Data Coordinating study at UNMC/NMC
Time frame: Ongoing
Web-based registries.
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
Time frame: Ongoing
Web-based registry.
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 10 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Kenneth H Cowan, MD, PhD principal investigator
University of Nebraska
65 sites 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 and Precancerous Condition, run by University of Nebraska at 65 sites 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 4 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites 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?
Implementation of a web-based Breast Cancer Collaborative Registry at the National Comprehensive Cancer Network (NCCN) centers (time frame: Ongoing). The study lists 3 primary outcomes in all. 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 10 Oct 2023.