Clinical trial NCT05205967: REFLECTION: A Clinical Practice Learning Program for Galleri®
Official title: REFLECTION: Real World Evidence for Learnings in Early Cancer Detection, a Clinical Practice Learning Program for Galleri®
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Early Detection of Cancer
Cancer
Keywords: Multi-cancer early detection
Cancer screening
Circulating cell-free tumor DNA
Lead sponsor: GRAIL, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-25
Enrollment: 17000
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will enroll approximately 17,000 participants who meet the defined eligibility criteria.

Brief summary: REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 17,000 individuals who have opted to be screened with Galleri®, a blood-based, multi-cancer early detection (MCED) test in routine clinical settings. The purpose of the study is to understand the real-world experience of Galleri® in clinical settings.


Eligibility criteria: Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

* Participant has the ability to understand and the willingness to sign a written informed consent form (ICF);
* Participant is at least 22 years old at the time of consent;
* A provider or their designee has ordered the Galleri® test; and
* Participant has the ability to comprehend the participant questionnaires.

Exclusion Criteria:

* There are no exclusions

Primary outcomes:
measure: To describe signal detection and cancer detection within and across sites among participants who opt to receive Galleri® in a real world setting.
timeFrame: Up to 12 Months
Secondary outcomes:
measure: Galleri®: To assess the feasibility and acceptability of Galleri® from the perspective of participants and patient-reported outcomes (PROs) in a real-world setting.
timeFrame: Up to 12 Months
measure: HCRU: To assess healthcare resource utilization (HCRU) associated with cancer diagnostic workups for participants with signal detected Galleri® test results.
timeFrame: Up to 12 Months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Vincere Cancer Center
state: Arizona
city: Burbank
country: United States
facility: Providence
state: California
city: Fullerton
country: United States
facility: Providence, St. Jude
state: California
city: Mission Viejo
country: United States
facility: Providence, Mission
state: California
city: Orange
country: United States
facility: Providence, Orange County
state: California
city: Saint Helena
country: United States
facility: St. Helena Hospital (Adventist Health)
state: California
city: Miami
country: United States
facility: VA Miami Health Care System
state: Florida
city: Tampa
country: United States
facility: James A. Haley Veterans Hospital (VA Tampa)
state: Florida
city: New Orleans
country: United States
facility: Southeast Louisiana Veterans Health Care System (SLVHCS) (VA New Orleans)
state: Louisiana
city: Boston
country: United States
facility: Boston VA Research Institute (VA Boston)
state: Massachusetts
city: Portland
country: United States
facility: Providence
state: Oregon
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: VA Wilkes Barre Medical Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Carolina Blood and Cancer Care Associate
state: South Carolina
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care Associates
state: South Carolina
city: Salt Lake City
country: United States
facility: VA Salt Lake City Health Care System (VASLCHCS)
state: Utah
city: Morgantown
country: United States
facility: WVU University Town Centre Family Medicine
state: West Virginia
Study officials:
References: