Connect for Cancer Prevention Study (Connect)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; General Research Use

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.

• Study Type: Observational
• Enrollment (Estimated): 200000

Contacts and Locations

• Study Contact: Name: Nicolas A Wentzensen, M.D.; Phone Number: (866) 462-6621; Email: ConnectPI@nih.gov

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80247
      • Recruiting
      • Kaiser Permanente Colorado
      • Contact: Heather Feigelson; Phone Number: Not Listed
  • Georgia
    • Atlanta, Georgia, United States, 30305
      • Recruiting
      • Kaiser Permanente Georgia
      • Contact: Jennifer Gande; Phone Number: Not Listed
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Recruiting
      • Kaiser Permanente Hawaii
      • Contact: Stacey Honda; Phone Number: Not Listed
  • Illinois
    • Chicago, Illinois, United States, 60603
      • Active, not recruiting
      • University of Chicago Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Health Systems
      • Contact: Benjamin Rybicki; Phone Number: Not Listed
  • Minnesota
    • Minneapolis, Minnesota, United States, 55425
      • Recruiting
      • HealthPartners
      • Contact: Pamela Pawloski; Phone Number: Not Listed
  • Oregon
    • Portland, Oregon, United States, 97086
      • Recruiting
      • Kaiser Permanente Northwest
      • Contact: Mark Schmidt; Phone Number: Not Listed
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117
      • Recruiting
      • Sanford Health
      • Contact: Chun-Hung Chan; Phone Number: Not Listed
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Scott and White Health
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • Recruiting
      • Marshfield Clinic Health System
      • Contact: Robert Greenlee; Phone Number: Not Listed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Nicolas A Wentzensen, M.D., National Cancer Institute (NCI)

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Estimated): December 31, 2070
• Study Completion (Estimated): December 31, 2070

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 6, 2026

More Information

Terms related to this study

• Keywords: Natural History; Urine; Risk Factors; Blood; Pathology; medical conditions
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 10000034; 000034-C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected Connect IPD will be provided to the scientific community following the governance principles outlined in the protocol.
• IPD Sharing Time Frame: Starting in 2023
• IPD Sharing Access Criteria: Please see Sections 8 and 9.11 of the protocol that address data sharing.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No