Connect for Cancer Prevention Study (Connect)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04609072 |
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Recruitment Status :
Recruiting
First Posted : October 30, 2020
Last Update Posted : March 10, 2022
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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 40 and 65 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 the MyConnect app using their email address or phone number. After creating an account, they will complete the informed consent process. All information shared through the MyConnect app 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 a prospective cohort study that will follow participants over time to study how the way we live, our genetics, and our health history affect the risk of cancer and other diseases.
People who join the study will have no history of invasive cancer. People remain eligible to join if they have or once had non-melanoma skin cancer, or a condition that may raise cancer risk (like ductal carcinoma in situ, or DCIS).
Most cancers take time to develop, and biological, behavioral, and environmental factors can all influence cancer development. To study how these factors may influence cancer risk, researchers will collect repeated exposure information through health surveys and biological samples including blood, urine, and saliva from participants.
Connect will use novel digital technologies and exposure and biomarker assessment tools to explore suspected and emerging factors that may influence cancer development. The Connect data system will be built within an efficient, flexible, and integrated cloud-hosted infrastructure that leverages modern interoperability standards. In this way, it will be an accessible research resource for current and future 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:
Patients or members of partner health care systems who are between the ages of 40 and 65 years old at enrollment and have no personal history of invasive cancer (other than non-melanoma skin cancer) are eligible to join the study. Connect aims to recruit 200,000 total participants.
Description of Sites Enrolling Participants:
Nine US integrated healthcare systems will enroll participants for Connect.
Study Duration:
Recruitment will last at least five years. Participants will be followed over the course of their lives. We expect data analysis to continue for decades.
Participant Activities:
In addition to allowi...
| Condition or disease |
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| Cancer General Research Use |
Show detailed description
| Study Type : | Observational |
| Estimated 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 : | July 26, 2021 |
| Estimated Primary Completion Date : | December 31, 2070 |
| Estimated Study Completion Date : | December 31, 2070 |
| Group/Cohort |
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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.
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- 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
- general research use [ Time Frame: year zero and onward ]The endpoints are limitless and could include methodological research, human biology, ancestry, evolution or health-related outcomes.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04609072
| Contact: Montserrat Garcia-Closas, M.D. | Not Listed | ConnectPI@nih.gov |
| United States, Colorado | |
| Kaiser Permanente Colorado | Recruiting |
| Denver, Colorado, United States, 80247 | |
| United States, Minnesota | |
| HealthPartners | Recruiting |
| Minneapolis, Minnesota, United States, 55425 | |
| United States, South Dakota | |
| Sanford Health | Recruiting |
| Sioux Falls, South Dakota, United States, 57117 | |
| United States, Wisconsin | |
| Marshfield Clinic Health System | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Principal Investigator: | Montserrat Garcia-Closas, M.D. | National Cancer Institute (NCI) |
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT04609072 |
| Other Study ID Numbers: |
10000034 000034-C |
| First Posted: | October 30, 2020 Key Record Dates |
| Last Update Posted: | March 10, 2022 |
| Last Verified: | March 8, 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Risk Factors medical conditions Pathology |
Blood Urine Natural History |