CCPW: Prevent Cancer- Greenville

Sponsor
Prisma Health-Upstate (Other)
Overall Status
Recruiting
CT.gov ID
NCT04947098
Collaborator
(none)
1,000
1
132
7.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Prospective
    Official Title:
    Prevent Cancer-Greenville: A Center for Cancer Prevention and Wellness Research Project
    Actual Study Start Date :
    Nov 8, 2018
    Anticipated Primary Completion Date :
    Nov 8, 2028
    Anticipated Study Completion Date :
    Nov 8, 2029

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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.

    9. 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.

    10. 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.

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 18 years or older

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prisma Health-Upstate Greenville South Carolina United States 29605

    Sponsors and Collaborators

    • Prisma Health-Upstate

    Investigators

    • Principal Investigator: Larry Gluck, MD, Prisma Health-Upstate

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Prisma Health-Upstate
    ClinicalTrials.gov Identifier:
    NCT04947098
    Other Study ID Numbers:
    • Pro00077309
    First Posted:
    Jul 1, 2021
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 21, 2022