Connect for Cancer Prevention Study (Connect)

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04609072
• Other study ID #: 10000034
• Secondary ID: 000034-C
• Status: Recruiting
• Start date: July 26, 2021
• Est. completion date: December 31, 2070

Study information

• Verified date: June 10, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Nicolas Wentzensen, M.D.
• Phone: (866) 462-6621
• Email: ConnectPI[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: December 31, 2070
• Est. primary completion date: December 31, 2070
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

• 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 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.

EXCLUSION CRITERIA:

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

• Individuals with a history of invasive cancer (other than non-melanoma skin cancer)

• Individuals with known cognitive impairment documented in their medical record

Related Conditions & MeSH terms

• Cancer
• General Research Use

Locations

Country	Name	City	State
United States	Kaiser Permanente Georgia	Atlanta	Georgia
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Kaiser Permanente Colorado	Denver	Colorado
United States	Henry Ford Health Systems	Detroit	Michigan
United States	Kaiser Permanente Hawaii	Honolulu	Hawaii
United States	Marshfield Clinic Health System	Marshfield	Wisconsin
United States	HealthPartners	Minneapolis	Minnesota
United States	Kaiser Permanente Northwest	Portland	Oregon
United States	Sanford Health	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	general research use	The endpoints are limitless and could include methodological research, human biology, ancestry, evolution or health-related outcomes.	year zero and onward

External Links

•   https://www.cancer.gov/connect-prevention-study/