Prevent Cancer- Greenville

Recruiting

• Conditions: Cancer; High-Risk Cancer

• Registration Number: NCT04947098
• Lead Sponsor: Prisma Health-Upstate

Brief Summary

Prevent Cancer-Greenville was created to provide individuals with the opportunity to have their risk of developing cancer studied. Some individuals may be at a higher risk due to their personal lifestyle, family history and/or exposures. If subjects are found to be at high risk for developing a disease, they will be sent to a healthcare provider for further care.

Detailed Description

Participants' personal history, lifestyle behaviors and blood, urine, and cheek swab specimens will be used to detect changes or trends that might put them at risk for developing cancer. Some individuals may be at an above average risk of cancer due to lifestyle, family background, personal genetic makeup, or environmental exposures. This will be determined by a process called risk stratification. Risk stratification involves looking at all health-related aspects of a person, determining their individualized risk through screening, and educating them on measures to reduce potential for disease. Participants will complete a yearly health assessment which includes measurements for nutrition, activity, individual risk factors and body composition, including weight height and a special scale which measures fluid and fat.

Study Timeline

• Study Start: 2018-11-08
• Study First Submitted: 2021-04-29
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-07-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2028-11-08
• Study Completion: 2029-11-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 18 years or older

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess changes in physical activity by physical activity questionnaire	Yearly follow up for 10 years	Physical activity will be assessed yearly a questionnaire based on physical activity recommendations from the U.S. Department of Health and Human Services.
Assess changes in alcohol use	Yearly follow up for 10 years	Participants will be educated on healthy lifestyle habits and alcohol use will be assessed yearly.
Assess hereditary risk through family history review	Yearly follow up for 10 years	Each participant's family history will be reviewed to make recommendations for screening or genetic testing based on National Comprehensive Cancer Network guidelines.
Assess changes in muscle mass by SOZO measurements	Yearly follow up for 10 years	Body composition will be assessed yearly by measurements taken from the SOZO device which uses bioimpedance spectroscopy to measure muscle mass.
Assess changes in nutrition by nutrition questionnaire	Yearly follow up for 10 years	Nutrition will be assessed yearly by a questionnaire based on nutrition recommendations from the American Institute for Cancer Research and the U.S. Department of Health and Human Services.
Assess changes in smoking habits	Yearly follow up for 10 years	Participants will be educated on healthy lifestyle habits and smoking habits will be assessed yearly.
Assess lifetime breast cancer risk through the Tyrer-Cuzick version 8 breast risk evaluation tool	Yearly follow up for 10 years	Participants' breast cancer risk will be assessed using the Tyrer-Cuzick breast cancer risk model. Participants will be referred to appropriate clinics if lifetime risk is greater than 20 percent.
Assess 5- year breast cancer risk through the GAIL breast risk evaluation tool	Yearly follow up for 10 years	Participants' breast cancer risk will be assessed using the National Cancer Institute's GAIL model. Participants will be referred to appropriate clinics if GAIL 5 year risk is greater than 1.7 percent.
Assess changes in fat mass by SOZO measurements	Yearly follow up for 10 years	Body composition will be assessed yearly by measurements taken from the SOZO device which uses bioimpedance spectroscopy to measure fat mass.
Early detection of malignancies through screening	Yearly follow up for 10 years	Participants will be educated on screening recommendations by the American Cancer Society. Malignancies will be recorded yearly if found by recommended screenings.

Secondary Outcome Measures

Name	Time	Method
Assess changes in quality of life by the 5-level EuroQol-5D version (EQ-5D-5L) questionnaire	Yearly follow up for 10 years	Quality of life will be assessed yearly by the EQ-5D-5L questionnaire. Participants' will self-report their health on a scale numbered 0-100. 100 means the best health you can imagine and 0 means the worst health you can imagine.

Trial Locations

Locations (1)

Prisma Health-Upstate; 🇺🇸 Greenville, South Carolina, United States