Prevent Cancer- Greenville

Cancer Clinical Trial

— CCPW  

Official title:

Prevent Cancer-Greenville: A Center for Cancer Prevention and Wellness Research Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04947098
• Other study ID #: Pro00077309
• Status: Recruiting
• Start date: November 8, 2018
• Est. completion date: November 8, 2029

Study information

• Verified date: November 2023
• Source: Prisma Health-Upstate
• Contact: Patricia Wilson, MSN
• Phone: 864-455-4897
• Email: ccpw[@]prismahealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 8, 2029
• Est. primary completion date: November 8, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

Related Conditions & MeSH terms

• Cancer
• High-Risk Cancer

Locations

Country	Name	City	State
United States	Prisma Health-Upstate	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess changes in nutrition by nutrition questionnaire	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.	Yearly follow up for 10 years
Primary	Assess changes in physical activity by physical activity questionnaire	Physical activity will be assessed yearly a questionnaire based on physical activity recommendations from the U.S. Department of Health and Human Services.	Yearly follow up for 10 years
Primary	Assess changes in smoking habits	Participants will be educated on healthy lifestyle habits and smoking habits will be assessed yearly.	Yearly follow up for 10 years
Primary	Assess changes in alcohol use	Participants will be educated on healthy lifestyle habits and alcohol use will be assessed yearly.	Yearly follow up for 10 years
Primary	Assess hereditary risk through family history review	Each participant's family history will be reviewed to make recommendations for screening or genetic testing based on National Comprehensive Cancer Network guidelines.	Yearly follow up for 10 years
Primary	Assess lifetime breast cancer risk through the Tyrer-Cuzick version 8 breast risk evaluation tool	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.	Yearly follow up for 10 years
Primary	Assess 5- year breast cancer risk through the GAIL breast risk evaluation tool	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.	Yearly follow up for 10 years
Primary	Early detection of malignancies through screening	Participants will be educated on screening recommendations by the American Cancer Society. Malignancies will be recorded yearly if found by recommended screenings.	Yearly follow up for 10 years
Primary	Assess changes in fat mass by SOZO measurements	Body composition will be assessed yearly by measurements taken from the SOZO device which uses bioimpedance spectroscopy to measure fat mass.	Yearly follow up for 10 years
Primary	Assess changes in muscle mass by SOZO measurements	Body composition will be assessed yearly by measurements taken from the SOZO device which uses bioimpedance spectroscopy to measure muscle mass.	Yearly follow up for 10 years
Secondary	Assess changes in quality of life by the 5-level EuroQol-5D version (EQ-5D-5L) questionnaire	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.	Yearly follow up for 10 years

External Links

•   Education resources
•   Genetic risk evaluation and recommendations
•   Screening guidelines