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This is a multi-site registry of patients receiving the Exact Sciences Multicancer Early Detection (MCED) test.
This study was designed to simulate a real-world application of Exact Science's Multicancer Early Detection (MCED) test. Participants will be offered the Exact Science's MCED test annually for 3 years. If at any point during those 3 years a participant is diagnosed with cancer, they will become ineligible for further testing. Data will be collected for 5 years following the baseline test.
There will be two data collection approaches as part of this study. The first will be collection of self-report data related to the testing experience. The second will be periodic and largely automated extraction of pre-specified data elements from existing electronic data sources. A comparison data set will be constructed from records of individuals who did not receive the MCED test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicancer Early Detection (MCED) cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exact Sciences Multicancer Early Detection (MCED) Test | Device | Exact Sciences MCED test, is a qualitative in vitro diagnostic (IVD) for the detection of alterations in circulating tumor DNA and tumor-associated protein levels, which are commonly associated with cancer. It is performed on plasma derived from peripheral blood specimens. |
| Measure | Description | Time Frame |
|---|---|---|
| Vital status | Particpant is alive or deceased | Up to 5 years |
| Cancer status | Presence or absence of cancer | Up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Cohort will consist of particpants who have scheduled appointments with their primary health care provider at the participating clinics.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deb Kettner-Sieber | Contact | 608-982-6734 | dkettnersieber@exactsciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Tomasz M Beer, MD | Exact Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endeavor Health | Recruiting | Evanston | Illinois | 60201 | United States |
Individual participant data that underlie the results reported in publications of the study will be shared after de-identification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable), and clinical study report (when applicable) will also be shared. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal.
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Data will be available from 2 years and ending 4 years after publication.
Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary Institutional Review Board (IRB)/Ethics Committee (EC) approvals or waivers as applicable to conduct research.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Baylor Scott & White Health | Recruiting | Dallas | Texas | 75246 | United States |
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