CancerNCT04609072
Connect for Cancer Prevention Study (Connect)
An observational study of Cancer and General Research Use, run by National Cancer Institute (NCI) at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, General Research Use
- How many people
- 200,000 participants
- Where
- 10 sitesUnited States
- Study dates
- 26 Jul 2021to 31 Dec 2070
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients or members of participating health care organizations around the U.S.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 9 recruiting
- Recruiting
Kaiser Permanente Georgia
Atlanta, Georgia, 30305
- Active, not recruiting
University of Chicago Medical Center
Chicago, Illinois, 60603
- Recruiting
Baylor Scott and White Health
Dallas, Texas, 75246
- Recruiting
Kaiser Permanente Colorado
Denver, Colorado, 80247
- Recruiting
Henry Ford Health Systems
Detroit, Michigan, 48202
- Recruiting
Kaiser Permanente Hawaii
Honolulu, Hawaii, 96814
- Recruiting
Marshfield Clinic Health System
Marshfield, Wisconsin, 54449
- Recruiting
HealthPartners
Minneapolis, Minnesota, 55425
- Recruiting
Kaiser Permanente Northwest
Portland, Oregon, 97086
- Recruiting
Sanford Health
Sioux Falls, South Dakota, 57117
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cancer, General Research Use
- Keywords
- Risk Factors, medical conditions, Pathology, Blood, Urine, Natural History
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: year one and onward
Secondary outcomes (1)
general research use
The endpoints are limitless and could include methodological research, human biology, ancestry, evolution or health-related outcomes.
Measured: year zero and onward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start26 Jul 2021
- Primary completion31 Dec 2070 (estimated)
- Study completion31 Dec 2070 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nicolas A Wentzensen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609072
- Sponsor's protocol ID
- 10000034
- Other IDs
- 000034-C
- Status last verified
- 20 Oct 2026
- First submitted
- 29 Oct 2020
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected Connect IPD will be provided to the scientific community following the governance principles outlined in the protocol.
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.
PubMed 29907587
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connect for Cancer Prevention Study: A Prospective Cohort Study Within Integrated Healthcare Systems in the US
- ClinicalTrials.gov ID
- NCT04609072
- Acronym / sponsor ID
- 10000034
- Conditions
- Cancer, General Research Use
- Keywords
- Risk Factors, medical conditions, Pathology, Blood, Urine, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 31 Dec 2070 (estimated)
- Study completion
- 31 Dec 2070 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients or members of participating health care organizations around the U.S.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cancer incidence, progression, and mortality
Time frame: 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
1 secondary outcome
general research use
Time frame: year zero and onward
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 29907587Rebbeck 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.
- https://www.cancer.gov/connect-prevention-study/Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected Connect IPD will be provided to the scientific community following the governance principles outlined in the protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas A Wentzensen, M.D. principal investigator
National Cancer Institute (NCI)
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and General Research Use, run by National Cancer Institute (NCI) at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas A Wentzensen, M.D. ((866) 462-6621, ConnectPI@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cancer incidence, progression, and mortality (time frame: year one and onward). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04609072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.