Connect for Cancer Prevention Study (Connect)

Study Overview
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Brief Summary
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Background: The National Cancer Institute, part of the National Institutes of Health, has partnered with nine health care systems across the U.S. to establish the Connect for Cancer Prevention Study. While researchers have made important discoveries, there is more to learn to lower the number of people affected by cancer. By taking part in Connect, participants can help researchers learn how the way we live, our genetics, and our health history may affect cancer risk. Objective: To study and better understand the causes of cancer and to find new ways to prevent it. Eligibility: The study will include 200,000 adults who get their health care from a partner health care system, are between 40 and 65 years old at enrollment, and have never had cancer. People remain eligible to join if they have or once had non-melanoma skin cancer, or a condition that may raise cancer risk (such as ductal carcinoma in situ, or DCIS). Design: Eligible recruits can sign up for Connect online by creating an account on the MyConnect app using their email address or phone number. After creating an account, they will complete the informed consent process. All information shared through the MyConnect app is secure to protect participant privacy. After joining the study, participants will be asked to answer online health surveys a few times a year, donate samples of blood, urine, and saliva every two to three years, and safely share access to their electronic health records with Connect. In the future, participants may donate unused samples that are collected at clinical visits, like tissue, stool, or blood, and may mail in samples collected at home. Participants may also share information from personal health trackers, like wearable devices or apps. This information will help researchers study the health and behavior patterns that may affect cancer risk. It takes time to understand the causes of cancer, so Connect will go on for many years. The longer people participate, the more researchers may learn. Participants can leave the study at any time. Learn more about Connect by visiting cancer.gov/connectstudy.

Detailed Description
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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 each.

Official Title
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Connect for Cancer Prevention Study: A Prospective Cohort Study Within Integrated Healthcare Systems in the US

Conditions
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Cancer, General Research Use

Participation Criteria
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Eligibility Criteria
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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 EXCLUSION CRITERIA: Individuals with a history of invasive cancer (other than non-melanoma skin cancer) Individuals with known cognitive impairment documented in their medical record

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy volunteers<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cancer incidence, progression, and mortality | 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 | year one and onward | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| general research use | The endpoints are limitless and could include methodological research, human biology, ancestry, evolution or health-related outcomes. | year zero and onward | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risk Factors, medical conditions, Pathology, Blood, Urine, Natural History