Clinical trial NCT04609072: 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
General Research Use
Keywords: Risk Factors
medical conditions
Pathology
Blood
Urine
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-10-30
Enrollment: 200000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients or members of participating health care organizations around the U.S.

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 criteria: * 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 at time of initial study invitation, 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 30 and 70 years old at study invitation

If an individual is determined to be ineligible at the time of enrollment due to age, the individual will be allowed to re-enroll at a later time once the recruit meets the age requirement. This includes recruits that did not meet the original age requirement of 40-65 years of age but now meet the updated age range of 30-70.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria at time of initial study invitation will be excluded from participation in this study:

* Individuals with a confirmed history of invasive cancer (other than non-melanoma skin cancer)
* Individuals with known cognitive impairment documented in their medical record

Primary outcomes:
measure: cancer incidence, progression, and mortality
timeFrame: year one and onward
Secondary outcomes:
measure: general research use
timeFrame: year zero and onward
Other outcomes:
Locations:
city: Denver
country: United States
facility: Kaiser Permanente Colorado
state: Colorado
city: Atlanta
country: United States
facility: Kaiser Permanente Georgia
state: Georgia
city: Honolulu
country: United States
facility: Kaiser Permanente Hawaii
state: Hawaii
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Detroit
country: United States
facility: Henry Ford Health Systems
state: Michigan
city: Minneapolis
country: United States
facility: HealthPartners
state: Minnesota
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Dallas
country: United States
facility: Baylor Scott and White Health
state: Texas
city: Marshfield
country: United States
facility: Marshfield Clinic Health System
state: Wisconsin
Study officials:
affiliation: National Cancer Institute (NCI)
name: Nicolas A Wentzensen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.