Clinical trial NCT04947098: Prevent Cancer- Greenville
Official title: Prevent Cancer-Greenville: A Center for Cancer Prevention and Wellness Research Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
High-Risk Cancer
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals 18 years or older

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.

Eligibility criteria: Inclusion Criteria:

* 18 years or older

Primary outcomes:
measure: Assess changes in nutrition by nutrition questionnaire
timeFrame: Yearly follow up for 10 years
measure: Assess changes in physical activity by physical activity questionnaire
timeFrame: Yearly follow up for 10 years
measure: Assess changes in smoking habits
timeFrame: Yearly follow up for 10 years
measure: Assess changes in alcohol use
timeFrame: Yearly follow up for 10 years
measure: Assess hereditary risk through family history review
timeFrame: Yearly follow up for 10 years
measure: Assess lifetime breast cancer risk through the Tyrer-Cuzick version 8 breast risk evaluation tool
timeFrame: Yearly follow up for 10 years
measure: Assess 5- year breast cancer risk through the GAIL breast risk evaluation tool
timeFrame: Yearly follow up for 10 years
measure: Early detection of malignancies through screening
timeFrame: Yearly follow up for 10 years
measure: Assess changes in fat mass by SOZO measurements
timeFrame: Yearly follow up for 10 years
measure: Assess changes in muscle mass by SOZO measurements
timeFrame: Yearly follow up for 10 years
Secondary outcomes:
measure: Assess changes in quality of life by the 5-level EuroQol-5D version (EQ-5D-5L) questionnaire
timeFrame: Yearly follow up for 10 years
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health-Upstate
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Joe Stephenson, MD
role: PRINCIPAL_INVESTIGATOR
References: