Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589310
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Falcon Real World Evidence Registry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Falcon - The Exact Sciences Multicancer Early Detection MCED Real World Evidence RWE Registry
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-site registry of patients receiving the Exact Sciences Multicancer Early Detection MCED test
Detailed Description:
This study was designed to simulate a real-world application of Exact Sciences Multicancer Early Detection MCED test Participants will be offered the Exact Sciences 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None