Susan G. Komen's ShareForCures

ShareForCures: Susan G. Komen's People-powered, Data-driven Breast Cancer Research Registry

ShareForCures (SFC) is a community-based participatory research registry, and its prime objective is to engage participants representative of the United States breast cancer patient population -including minoritized and historically marginalized people, persons, or communities-to ensure the data researchers use to study breast cancer is as diverse as the people touched by this disease. In doing so, researchers will have a better understanding of breast cancer, and everyone can potentially benefit from scientific advances and improvements in care.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer

Detailed Description

ShareForCures (SFC) will be a people-powered, data-driven breast cancer registry that will provide a way for individuals from diverse backgrounds to participate in research and enable participants' data to be used for breast cancer research. The overarching goal of SFC is to create a robust research resource comprised of clinical, biological, socio-behavioral, and other data from up to 200,000 people with breast cancer-including minoritized and historically marginalized people, persons, or communities-to ensure the data, researchers use to study breast cancer, is as diverse as the people touched by this disease. In doing so, researchers will have a better understanding of breast cancer and everyone can potentially benefit from scientific advances and improvements in care.

• Study Type: Observational
• Enrollment (Estimated): 200000

Contacts and Locations

• Study Contact: Name: Jerome Jourquin, Ph.D., M.S.; Phone Number: 1-877-465-6636; Email: JJourquin@komen.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75380
      • Recruiting
      • Susan G. Komen
      • Contact: Jerome Jourquin, Ph.D., M.S.; Phone Number: 877-465-6636; Email: JJourquin@komen.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ShareForCures is open to all individuals diagnosed with breast cancer, age 18 and older, of any gender, and all racial and ethnic origins living in the United States.

Description

Inclusion Criteria:

• Individuals must be at least 18 years old. (Individuals in Alabama and Nebraska must be over 19 and individuals in Mississippi and Pennsylvania must be over 21 to participate).
• Individuals must have been diagnosed with cancer originating (or is suspected to originate) from the breast.
• Individuals must be currently residing in the United States or a territory of the United States.
• Individuals must be able to read and understand English.

Exclusion Criteria:

• Individuals under the age of 18 years. (Individuals in Alabama and Nebraska under 19 and individuals in Mississippi and Pennsylvania under 21 are not eligible to participate).
• Individuals without a diagnosis of breast cancer.
• Individuals who are not residing in the United States or a territory of the United States.
• Individuals unable to read and understand English.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engage participants representative of the United States breast cancer patient population in ShareForCures.	Enroll and engage up to 200,000 people, who have been diagnosed with breast cancer, reflecting the diversity of breast cancer survivors within the United States, to participate in the registry as our partners in research.	10 years
Integrate participant data into ShareForCures.	Collect and curate a rich scope of participant data from a variety of sources (including participant-provided information, clinical records, and linkage to other existing datasets) and biospecimens to create a comprehensive, longitudinal database.	10 years
Facilitate scientific research using ShareForCures data.	Make deidentified data available to researchers for scientific discoveries, including research that may lead to new knowledge about breast cancer and advances in patient care and outcomes.	10 years

Collaborators and Investigators

• Sponsor: Susan G. Komen Breast Cancer Foundation
• Investigators: Principal Investigator: Jerome Jourquin, Ph.D., M.S., Susan G. Komen

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2022
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): November 1, 2032

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SGK-SFC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Researchers may request access to SFC data, and upon approval may use the data to answer research questions including studies that will lead to new knowledge about breast cancer and advances in patient care and outcomes.

All data sharing will be handled securely and under IRB approval or exemption, following rigorous standards to protect individual privacy and data confidentiality.

• IPD Sharing Time Frame: Once enough data have been aggregated in ShareForCures, researchers will be able to request access to ShareForCures deidentified data. Data will be available for the duration of the study.
• IPD Sharing Access Criteria: Researchers will be required to formally request access to the data. All requests will be reviewed according to Komen's Data Request Review Process. Researchers will also need to execute a Data Transfer and Use Agreement (DTUA), comply with the Researcher Code of Conduct, and abide by other Komen policies and procedures, as needed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No