Connect for Cancer Prevention Study (Connect)

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT04609072
Collaborator
(none)
200,000
Enrollment
3
Locations
593.2
Anticipated Duration (Months)
66666.7
Patients Per Site
112.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Background:

Most cancers develop over long periods of time. Many things can affect how cancer develops and changes. Researchers want to use new technology and methods to study the things that can affect cancer risk. They will collect information from people over many years and use this information to build a state-of-the-art research resource to better understand the causes of cancer.

Objective:

To study and better understand what causes cancer and to find new ways to prevent or treat it.

Eligibility:

Adults ages 40-65 who get their health care from a partner health care system and do not have a previous or current cancer diagnosis (an exception is that people with non-melanoma skin cancer may join).

Design:

Participants will create an account on the MyConnect app using their phone number or email address. They will share their name, date of birth, address, and other contact information.

When they join, participants will complete four online surveys. The surveys will ask about their health, habits, family, home, and work. They will be contacted about completing other surveys at least once a year. Participants will donate biological specimens, which are samples of things like blood, urine, and saliva.

Participants will share their health and medical records. They may donate unused specimens that are collected at clinical visits, like tissue, stool, or blood. They may also mail in samples taken at home. Participants may share information from personal health trackers, like wearable devices or apps.

Participants will be contacted via email, telephone, text message, postal mail, health care system patient portal, or notifications on the MyConnect app.

Connect participants will be part of the study throughout their lives. Participants can leave the study at any time.

Condition or DiseaseIntervention/TreatmentPhase

    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 prospective 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 provide this rich database and biorepository for general research use.

    Endpoints:

    The primary endpoints are the continuum of cancer incidence, progression, and survival. Secondary endpoints are numerous and could include methodological research, human biology, ancestry, evolution or health-related outcomes.

    Study Population:

    At least to 200,000 adults aged 40 to 65 years, no personal history of invasive cancer, and patients or members of participating integrated health care systems are eligible to participate.

    Description of Sites/Facilities Enrolling Participants:

    Nine US integrated healthcare systems will host enrollment.

    Study Duration:

    Recruitment will last at least five years. Participants will be followed for life. Analysis of the data is expected to continue for the foreseeable future.

    Participant Duration:

    Completion of the baseline study activities will take participants approximately four hours. Subsequent activities are expected to take one to four hours.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Connect for Cancer Prevention Study: A Prospective Cohort Study Within Integrated Healthcare Systems in the US
    Actual Study Start Date :
    Jul 26, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2070
    Anticipated Study Completion Date :
    Dec 31, 2070

    Arms and Interventions

    ArmIntervention/Treatment
    Healthy volunteers

    Up to 200,000 men and women aged 40 to 65 years, with no personal history of cancer, and patients or members of participating integrated health care systems.

    Outcome Measures

    Primary Outcome Measures

    1. cancer incidence, progression, and mortality [year one and onward]

      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

    Secondary Outcome Measures

    1. general research use [year zero and onward]

      The endpoints are limitless and could include methodological research, human biology, ancestry, evolution or health-related outcomes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    • 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 40 and 65 years old at study invitation

    EXCLUSION CRITERIA:

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

    Individuals with known cognitive impairment documented in their medical record

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1HealthPartnersMinneapolisMinnesotaUnited States55425
    2Sanford HealthSioux FallsSouth DakotaUnited States57117
    3Marshfield Clinic Health SystemMarshfieldWisconsinUnited States54449

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Montserrat Garcia-Closas, M.D., National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT04609072
    Other Study ID Numbers:
    • 10000034
    • 000034-C
    First Posted:
    Oct 30, 2020
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Nov 12, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Cancer Institute (NCI)

    Study Results

    No Results Posted as of Dec 3, 2021