Clinical trial NCT05673018: Galleri in the Medicare Population
Official title: REACH Study: Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: ctDNA, Circulating tumor DNA, Screening, Cancer
Lead sponsor: GRAIL, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-05
Enrollment: 50000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The parallel arm is a passively-enrolled contemporaneous comparator cohort of Medicare beneficiaries who receive usual care without MCED screening.
Primary purpose: SCREENING

Brief summary: This multi-center comparative prospective cohort study is designed to assess the real world clinical impact, including safety and test performance, of Galleri®, a blood-based multi-cancer early detection (MCED) test. The study will seek to enroll approximately 20% of the study participants from under-represented minority populations (e.g., racial / ethnic minority groups, socioeconomically disadvantaged populations, rural populations).


Eligibility criteria: Inclusion Criteria:

For Galleri + UC (Galleri-Tested Arm):

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

* Aged ≥50 years with Medicare coverage,
* Eligible to receive the Galleri test, based on a determination by the study investigator or designee that the test is clinically appropriate,
* Capable of giving informed consent that is legally effective (consent provided by a legally authorized representative is not permitted in this protocol), and
* Able to comprehend and respond to questions in participant questionnaires. Comprehension level is determined by the study investigator or designee.

For UC (Not Galleri-tested Arm):

* Aged ≥ 50 years with Medicare coverage,
* Have had ≥ 1 UC visit

Exclusion Criteria:

For Galleri + UC (Galleri-Tested Arm):

* Having had a previous Galleri test not associated with this study.
* Undergoing clinical evaluation for symptoms suspicious for cancer.
* Personal history of invasive solid tumor or hematologic malignancy, diagnosed within the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior to expected enrollment date and never treated.
* Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded.
* Prior/Concurrent Concomitant Therapy (Medications/Treatments):
* Definitive treatment for invasive solid tumor or hematologic malignancy within the 3 years prior to expected enrollment date.
* Adjuvant hormone therapy for cancer (i.e., for breast or prostate cancer) is not an exclusion criterion.
* Current pregnancy
* Individuals who will not be able to comply with the protocol procedures.
* Individuals who are not currently registered patients at a participating center.
* Previous or current employees or contractors of GRAIL.

For UC (Not Galleri-tested Arm):

* Undergoing or referred for diagnostic evaluation due to clinical suspicion for cancer (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality).
* Personal history of invasive solid tumor or hematologic malignancy, diagnosed within the 3 years prior to expected enrollment date, or diagnosed greater than 3 years prior to expected enrollment date and never treated.
* Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded.
* Prior/Concurrent Concomitant Therapy (Medications/Treatments):
* Definitive treatment for invasive solid tumor or hematologic malignancy within the 3 years prior to expected enrollment date.
* Adjuvant hormone therapy for cancer (e.g. for breast or prostate cancer) is not an exclusion criterion.
* Current pregnancy.

Primary outcomes:
measure: Incidence rates of stage IV cancers
timeFrame: Up to 3 Years
Secondary outcomes:
measure: Safety: Number and type of invasive procedures performed to evaluate a cancer signal detected test result
timeFrame: Up to 3 Years
measure: Galleri test performance in the Galleri + UC arm
timeFrame: Up to 3 Years
measure: Adherence to guideline-recommended cancer screening in the Galleri+UC arm and UC arm over time
timeFrame: Up to 3 Years
measure: Healthcare resource utilization associated with cancer diagnostic evaluations in the Galleri+UC arm and UC arm
timeFrame: Up to 3 Years
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Sutter Valley Hospitals Auburn
state: California
city: Davis
country: United States
facility: Sutter Valley Hospitals Davis
state: California
city: Elk Grove
country: United States
facility: Sutter Valley Hospitals Elk Grove
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial
state: California
city: Modesto
country: United States
facility: Sutter Valley Hospitals Modesto
state: California
city: Palo Alto
country: United States
facility: Sutter Valley Hospitals PAMF Sutter
state: California
city: Roseville
country: United States
facility: Sutter Valley Hospitals Roseville
state: California
city: Sacramento
country: United States
facility: Sutter Valley Hospitals Alhambra
state: California
city: Sacramento
country: United States
facility: Sutter Valley Hospitals Capitol Pavilion
state: California
city: Santa Cruz
country: United States
facility: Sutter Valley Hospitals PAMF Santa Cruz
state: California
city: Sunnyvale
country: United States
facility: Sutter Valley Hospitals PAMF Sunnyvale
state: California
city: Vallejo
country: United States
facility: Sutter Valley Hospitals Fairfield
state: California
city: Anderson
country: United States
facility: Community Health Network Anderson
state: Indiana
city: Fishers
country: United States
facility: Community Health Network North
state: Indiana
city: Indianapolis
country: United States
facility: Community Health Network East
state: Indiana
city: Indianapolis
country: United States
facility: Community Health Network South
state: Indiana
city: Kokomo
country: United States
facility: Community Health Network Kokomo
state: Indiana
city: Baton Rouge
country: United States
facility: Ochsner Health Bocage
state: Louisiana
city: Baton Rouge
country: United States
facility: Ochsner Health Grove
state: Louisiana
city: Covington
country: United States
facility: Ochsner Health Covington
state: Louisiana
city: Covington
country: United States
facility: Ochsner Health St. Tammany Parish
state: Louisiana
city: Covington
country: United States
facility: Ochsner Health STCC
state: Louisiana
city: Lafayette
country: United States
facility: Ochsner Health Lafayette
state: Louisiana
city: Marrero
country: United States
facility: Ochsner Health Westbank
state: Louisiana
city: Metairie
country: United States
facility: Ochsner Health Lafreniere
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Health Benson
state: Louisiana
city: Saint Louis
country: United States
facility: Mercy Health St. Louis
state: Missouri
city: Springfield
country: United States
facility: Mercy Health - Springfield
state: Missouri
city: Beaverton
country: United States
facility: OHSU CEDAR Clinical Trials Beaverton
state: Oregon
city: Hillsboro
country: United States
facility: OHSU CEDAR Clinical Trials Orenco
state: Oregon
city: Portland
country: United States
facility: OHSU CEDAR Clinical Trials Portland
state: Oregon
city: Portland
country: United States
facility: OHSU CEDAR Clinical Trials Richmond
state: Oregon
Study officials:
References: