The RISC Registry--Risk Informed Screening Registry (RISC)

The Risk Informed Screening Registry (The RISC Registry)

Health inequities are defined as systemic differences in the health status of different population groups. It is well established that there are many sources of health inequity in oncology including differences in mortality, cancer screening uptake, time to diagnosis and disparities in access to treatment and care.

Routine cancer screening and effective surveillance and follow up are some of the most effective ways to reduce the burden of cancer across an individual's lifetime and at the population level. While there is a lack of screening tests for many cancers, breast cancer, the second highest leading cause of cancer death in women, has a plethora of validated screening and risk reduction approaches which can yield earlier detection and effective ways of treating and following women at risk and with breast cancer and improve outcomes.

However, there is uneven adoption and inconsistent use of these technologies and care practices.

The RISC Registry is an observational study that seeks to understand the application of risk-informed screening and care approaches and pursue the hypothesis that these screening approaches accompanied by population appropriate methods of clinician and patient engagement may increase understanding and compliance with screening, surveillance and follow up recommendations by empowering people to make healthier choices, and support addressing disparities in screening and patient care.

The primary focus is cancer screening with a focus on Precision Screening. (Precision Screening attempts to separate those who will benefit from screening from those that may not, through use of information on disease risk.) The study will start by focusing on women and breast cancer risk.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Risk
• Intervention / Treatment: Behavioral: Cancer Risk Screening and Follow up

Detailed Description

The RISC Registry (the "Registry" ) is a longitudinal observational database designed to capture health information to help develop individualized disease risk and care plans in varied patient populations and study how that information impacts physician recommendations and patient compliance.

The Registry was designed by a board of Scientific Advisors who are active users of risk assessment tools, and risk-informed screening protocols, including physicians, nurses, and patient advocates. Technology professionals and site administrators were also consulted regarding optimizing the process of data collection and dissemination. The Registry uses widely accepted standards for risk and disease classifications, results, management, and validated quality-of-life measures.

The Registry is vendor-agnostic and product-agnostic. This study will make a special effort to reach women who have historically been underserved by recruiting patients broadly distributed across different socioeconomic groups, ethnicities and diverse geographic areas.

The RISC Registry will help determine the ongoing value of Precision Screening in different clinical patient populations, shape guidelines for screening and optimal patient management, and support improvements in Precision Health and Precision Medicine support technology.

Eligible subjects will be offered personalized risk assessments and care plans at no charge to reduce cost as a barrier to screening.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Mary Kay Hardwick, MBA; Phone Number: 5106826256; Email: mk@phei.org
• Study Contact Backup: Name: Greg Wolff; Email: greg@phei.org

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94301
      • PHEI--Precision Health Equity Initiative
      • Contact: Mary Kay Hardwick; Phone Number: 510-682-6256; Email: mk@phei.org
      • Contact: Greg Wolff; Phone Number: 650-744-3744; Email: greg@phei.org
      • Principal Investigator: Rakesh Patel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Inclusive study of women who are seeking screening for breast cancer

Description

Inclusion Criteria:

• Female (Sex assigned at birth)
• Unaffected women--have never had breast cancer
• Females who have been diagnosed with breast cancer
• Females who are presenting for cancer screening
• Ages 18+
• Willing to sign a study consent form
• Willing to participate in PRO surveys
• Willing to use technology to participate in the study procedures , if and as needed

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician: Types of clinical management recommendations made based on the risk assessment and care plan options	Types of recommendations may include mammography or other types of imaging, frequency of imaging, other types of tests to assess risk	Within 1 month
Clinician: % of time clinician recommendations were made and/or changed based on the different risk model information presented	Changes to recommendations based on new risk informed assessments	Within 1 month
PRO--Patient Reported Outcomes: % of time patient screening behaviors changed based on recommendations made by shared decision making with the clinician	Patient behavior correlated with recommendations evaluated by type of method of engagement and various social determinants of health.	Within 3 months

Collaborators and Investigators

• Sponsor: Precision Health Equity Initiative
• Investigators: Principal Investigator: Rakesh Patel, MD, Precision Health Equity Initiative

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): June 1, 2033
• Study Completion (Anticipated): June 1, 2033

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RISC 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If PHEI does share participant data it will be after review by the PHEI Scientific Advisory Committee and all data will be de-indentified.

Drug and device information, study documents

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