Falcon Real World Evidence Registry

Recruiting

• Conditions: Cancer
• Interventions: Device: Exact Sciences Multicancer Early Detection (MCED) Test

• Registration Number: NCT06589310
• Lead Sponsor: Exact Sciences Corporation

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 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.

Study Timeline

• Study Start: 2024-08-01
• Study First Submitted: 2024-08-19
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-05
• Study First Posted: 2024-09-19
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-11
• Primary Completion: 2030-08
• Study Completion: 2031-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25000

Inclusion Criteria

• Participant age at time of consent is between 50 and 80 years
• Agree to receive the Exact Sciences MCED test and follow-up imaging
• Willing and able to provide informed consent
• Access to a suitable technology and willing to complete surveys electronically

Exclusion Criteria

• Any invasive tumor (excluding non-melanoma skin cancers) or hematological malignancy in the previous three years or current suspicion of cancer and/or in active treatment (e.g., chemotherapy, radiation therapy, immunotherapy, and/or surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multicancer Early Detection (MCED) cohort	Exact Sciences Multicancer Early Detection (MCED) Test	-

Primary Outcome Measures

Name	Time	Method
Vital status	Up to 5 years	Particpant is alive or deceased
Cancer status	Up to 5 years	Presence or absence of cancer

Trial Locations

Locations (2)

Endeavor Health; 🇺🇸 Evanston, Illinois, United States

Baylor Scott & White Health; 🇺🇸 Dallas, Texas, United States