Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cancer
  • General Research Use
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 40 years and 65 years
Gender
Both males and females

Description

Study Description: Connect is an observational cohort study that will prospectively collect exposure information and biospecimens and follow participants for cancer and other endpoints. Participants will be free of cancer at study invitation. Because most cancers develop over long periods of time an...

Study Description: Connect is an observational cohort study that will prospectively collect exposure information and biospecimens and follow participants for cancer and other endpoints. Participants will be free of cancer at study invitation. Because most cancers develop over long periods of time and biological, behavioral and environmental factors can influence cancer development and change over time, participants will be asked to provide repeated exposure information and biological specimens. The study protocol takes advantage of developments in digital technologies as well as exposure and biomarker assessment tools to investigate suspected and emerging factors that can influence cancer development. The study data system will be built within an efficient, flexible and integrated cloud-hosted infrastructure that leverages modern interoperability standards in order to be an accessible research resource for current and future generations of scientists. Objectives: The primary objective is to build a prospective cohort in the US using new technologies and methods to provide a diverse and comprehensive research resource for the scientific community to study: cancer etiology precursor to tumor transformation cancer risk assessment early detection of cancer second cancer development and survivorship after a cancer diagnosis The secondary objective is to provide this rich database and biorepository for general research use. Endpoints: The primary endpoints are the continuum of cancer incidence, progression, and survival. Secondary endpoints are numerous and could include methodological research, human biology, ancestry, evolution or health-related outcomes. Study Population: At least to 200,000 adults aged 40 to 65 years, no personal history of invasive cancer, and patients or members of participating integrated health care systems are eligible to participate. Description of Sites/Facilities Enrolling Participants: Nine US integrated healthcare systems will host enrollment. Study Duration: Recruitment will last at least five years. Participants will be followed for life. Analysis of the data is expected to continue for the foreseeable future. Participant Duration: Completion of the baseline study activities will take participants approximately four hours. Subsequent activities are expected to take one to four hours.

Tracking Information

NCT #
NCT04609072
Collaborators
Not Provided
Investigators
Principal Investigator: Montserrat Garcia-Closas, M.D. National Cancer Institute (NCI)