Connect for Cancer Prevention Study (Connect)

NCT04609072 | Recruiting

• 2 other identifiers: 10000034000034-C
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 10

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.

Conditions

Cancer; General Research Use

Keywords

Risk Factors; medical conditions; Pathology; Blood; Urine; Natural History

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• general research use

  year zero and onward

Study Arms (1)

Healthy volunteers

Up to 200,000 men and women aged 30 to 70 years, with no personal history of cancer, and patients or members of participating integrated health care systems.

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients or members of participating health care organizations around the U.S.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (10)

Kaiser Permanente Colorado

Denver, Colorado, 80247, United States

RECRUITING

Kaiser Permanente Georgia

Atlanta, Georgia, 30305, United States

RECRUITING

Kaiser Permanente Hawaii

Honolulu, Hawaii, 96814, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60603, United States

ACTIVE NOT RECRUITING

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

RECRUITING

HealthPartners

Minneapolis, Minnesota, 55425, United States

RECRUITING

Kaiser Permanente Northwest

Portland, Oregon, 97086, United States

RECRUITING

Sanford Health

Sioux Falls, South Dakota, 57117, United States

RECRUITING

Baylor Scott and White Health

Dallas, Texas, 75246, United States

RECRUITING

Marshfield Clinic Health System

Marshfield, Wisconsin, 54449, United States

RECRUITING

Related 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.

  PMID: 29907587 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Neoplasms

Study Officials

• Nicolas A Wentzensen, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas A Wentzensen, M.D.

CONTACT

(866) 462-6621; ConnectPI@nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: October 30, 2020
• Study Start: July 26, 2021
• Primary Completion (Estimated): December 31, 2070
• Study Completion (Estimated): December 31, 2070
• Last Updated: April 27, 2026

Record last verified: 2026-04-23

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Starting in 2023
• Access Criteria: Please see Sections 8 and 9.11 of the protocol that address data sharing.

Locations

US (10)