Connect for Cancer Prevention Study (Connect)
Most cancers develop over long periods of time. Many things can affect how cancer develops and changes. Researchers want to use new technology and methods to study the things that can affect cancer risk. They will collect information from people over many years and use this information to build a state-of-the-art research resource to better understand the causes of cancer.
To study and better understand what causes cancer and to find new ways to prevent or treat it.
Adults ages 40-65 who get their health care from a partner health care system and do not have a previous or current cancer diagnosis (an exception is that people with non-melanoma skin cancer may join).
Participants will create an account on the MyConnect app using their phone number or email address. They will share their name, date of birth, address, and other contact information.
When they join, participants will complete four online surveys. The surveys will ask about their health, habits, family, home, and work. They will be contacted about completing other surveys at least once a year. Participants will donate biological specimens, which are samples of things like blood, urine, and saliva.
Participants will share their health and medical records. They may donate unused specimens that are collected at clinical visits, like tissue, stool, or blood. They may also mail in samples taken at home. Participants may share information from personal health trackers, like wearable devices or apps.
Participants will be contacted via email, telephone, text message, postal mail, health care system patient portal, or notifications on the MyConnect app.
Connect participants will be part of the study throughout their lives. Participants can leave the study at any time.
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.
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:
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.
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.
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.
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.
Completion of the baseline study activities will take participants approximately four hours. Subsequent activities are expected to take one to four hours.
Arms and Interventions
Up to 200,000 men and women aged 40 to 65 years, with no personal history of cancer, and patients or members of participating integrated health care systems.
Primary Outcome Measures
- cancer incidence, progression, and mortality [year one and onward]
cancer incidence, progression, and mortality outcomes could include, but are not limited to:early biological effects (e.g., inflammation or metabolomic markers) related to cancer, intermediate biomarkers, cancer precursors, cancer risk factors, cancer incidence, cause of death, cancer survival, risk of second cancers and survivorship
Secondary Outcome Measures
- general research use [year zero and onward]
The endpoints are limitless and could include methodological research, human biology, ancestry, evolution or health-related outcomes.
- INCLUSION CRITERIA:
Due to the minimal risk nature of this protocol, all individuals interested and able to participate in Connect for Cancer Prevention, who meet the eligibility criteria and are not specifically excluded, will be able to participate. In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Patients or members of participating IHCS at the time of enrollment
Age between 40 and 65 years old at study invitation
Individuals with a history of invasive cancer (other than non-melanoma skin cancer)
Individuals with known cognitive impairment documented in their medical record
Contacts and Locations
|2||Sanford Health||Sioux Falls||South Dakota||United States||57117|
|3||Marshfield Clinic Health System||Marshfield||Wisconsin||United States||54449|
Sponsors and Collaborators
- National Cancer Institute (NCI)
- Principal Investigator: Montserrat Garcia-Closas, M.D., National Cancer Institute (NCI)
Study Documents (Full-Text)None provided.
- Rebbeck TR, Burns-White K, Chan AT, Emmons K, Freedman M, Hunter DJ, Kraft P, Laden F, Mucci L, Parmigiani G, Schrag D, Syngal S, Tamimi RM, Viswanath K, Yurgelun MB, Garber JE. Precision Prevention and Early Detection of Cancer: Fundamental Principles. Cancer Discov. 2018 Jul;8(7):803-811. doi: 10.1158/2159-8290.CD-17-1415. Epub 2018 Jun 15. Review.