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Spots Global Cancer Trial Database for Connect for Cancer Prevention Study (Connect)

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Trial Identification

Brief Title: Connect for Cancer Prevention Study (Connect)

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

Study ID: NCT04609072

Interventions

Study Description

Brief Summary: 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 30 and 70 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 MyConnect using their email address or phone number. After creating an account, they will complete the informed consent process. All information shared through MyConnect 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: 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 state-of-the-art 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 establish a rich database connected to a biorepository for general research use. Endpoints: The primary endpoints are the continuum of cancer incidence, detection, progression, and survival. Secondary endpoints are numerous and could include methodological research, human biology, ancestry, evolution or health-related outcomes.

Eligibility

Minimum Age: 30 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Kaiser Permanente Colorado, Denver, Colorado, United States

Kaiser Permanente Georgia, Atlanta, Georgia, United States

Kaiser Permanente Hawaii, Honolulu, Hawaii, United States

University of Chicago Medical Center, Chicago, Illinois, United States

Henry Ford Health Systems, Detroit, Michigan, United States

HealthPartners, Minneapolis, Minnesota, United States

Kaiser Permanente Northwest, Portland, Oregon, United States

Sanford Health, Sioux Falls, South Dakota, United States

Marshfield Clinic Health System, Marshfield, Wisconsin, United States

Contact Details

Name: Nicolas Wentzensen, M.D.

Affiliation: National Cancer Institute (NCI)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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