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Recruiting NCT04947098

Prevent Cancer- Greenville

Observational Cancer High-Risk Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cancer, High-Risk Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Assess changes in nutrition by nutrition questionnaire [Time frame: Yearly follow up for 10 years]
  • Assess changes in physical activity by physical activity questionnaire [Time frame: Yearly follow up for 10 years]
  • Assess changes in smoking habits [Time frame: Yearly follow up for 10 years]
  • Assess changes in alcohol use [Time frame: Yearly follow up for 10 years]
  • Assess hereditary risk through family history review [Time frame: Yearly follow up for 10 years]
  • Assess lifetime breast cancer risk through the Tyrer-Cuzick version 8 breast risk evaluation tool [Time frame: Yearly follow up for 10 years]
  • Assess 5- year breast cancer risk through the GAIL breast risk evaluation tool [Time frame: Yearly follow up for 10 years]
  • Early detection of malignancies through screening [Time frame: Yearly follow up for 10 years]
  • Assess changes in fat mass by SOZO measurements [Time frame: Yearly follow up for 10 years]
  • Assess changes in muscle mass by SOZO measurements [Time frame: Yearly follow up for 10 years]
Secondary outcome measures (1)
  • Assess changes in quality of life by the 5-level EuroQol-5D version (EQ-5D-5L) questionnaire [Time frame: Yearly follow up for 10 years]

Eligibility criteria

Inclusion criteria

  • 18 years or older

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Ecologic or community

Study locations

United States · 1 center
  • Prisma Health-Upstate — Greenville

Identifiers

NCT: NCT04947098 · Pro00077309

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗