Prevent Cancer- Greenville

NCT04947098 | Recruiting

• 1 other identifier: Pro00077309
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; High-Risk Cancer

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Assess changes in quality of life by the 5-level EuroQol-5D version (EQ-5D-5L) questionnaire

  Yearly follow up for 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals 18 years or older

You may qualify if:

• years or older

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health-Upstate

Greenville, South Carolina, 29605, United States

RECRUITING

Related Links

• Education resources
• Screening guidelines

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and cheek swab specimens will be collected.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Joe Stephenson, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Wilson, MSN Ed. OCN ONNCG

CONTACT

864-455-4897; ccpw@prismahealth.org

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: July 1, 2021
• Study Start: November 8, 2018
• Primary Completion (Estimated): November 8, 2028
• Study Completion (Estimated): November 8, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR

Locations

US (1)