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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04947098
Other study ID # Pro00077309
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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