Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50000 participants
INTERVENTIONAL
2024-07-12
2030-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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(Galleri + UC)
Medicare beneficiaries who receive the Galleri test plus usual care (Galleri + UC).
Multi-Cancer Early Detection Test (Galleri®)
Blood collection and multi-cancer early detection testing with return of results.
(UC) alone
Passively-enrolled Contemporaneous Comparator Arm of Medicare beneficiaries who receive usual care (UC) alone.
No interventions assigned to this group
Interventions
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Multi-Cancer Early Detection Test (Galleri®)
Blood collection and multi-cancer early detection testing with return of results.
Eligibility Criteria
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Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
* Aged ≥50 years with Medicare coverage, including Traditional Medicare (Part A \& B or Dual Eligibles) or Medicare Advantage.
* Capable of giving informed consent that is legally effective (consent provided by a legally authorized representative is not permitted in this protocol).
For UC (Not 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, including Traditional Medicare (Part A \& B or Dual Eligibles) or Medicare Advantage.
* Have had ≥ 1 UC visit
Exclusion Criteria
* Evidence of having had a previous MCED test (including but not limited to the Galleri test, e.g. CancerSeek, PanSeer). Participation in a study such as GRAIL's STRIVE study where results were not returned is not an exclusion criterion.
* Undergoing clinical evaluation for suspicion of cancer within 6 months prior to enrollment. Personal history of hematologic malignancy and/or invasive solid tumor (excluding non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin):
1. Diagnosed ≤3 years before expected enrollment date and/or
2. Diagnosed \>3 years before expected enrollment date and never treated and/or
3. Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).
* Current pregnancy.
* Individuals who are currently inpatients at a participating site.
* Individuals who are not willing or 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):
* Evidence of having had a previous MCED test (including but not limited to the Galleri test, eg.CancerSeek, PanSeer). Participation in a study such as GRAIL's STRIVE study where results were not returned is not an exclusion criterion.
* Undergoing clinical evaluation for suspicion of cancer.
* Personal history of hematologic malignancy and/or invasive solid tumor (not including non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin):
1. Diagnosed ≤3 years before expected enrollment date and/or
2. Diagnosed \>3 years before expected enrollment date and never treated and/or
3. Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).
* Current pregnancy.
* Individuals who are currently inpatients at a participating site.
50 Years
ALL
Yes
Sponsors
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GRAIL, Inc.
INDUSTRY
Responsible Party
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Locations
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Sutter Valley Hospitals Auburn
Auburn, California, United States
Sutter Valley Hospitals Davis
Davis, California, United States
Sutter Valley Hospitals Elk Grove
Elk Grove, California, United States
Long Beach Memorial Orange Coast
Fountain Valley, California, United States
Long Beach Memorial Saddleback
Laguna Hills, California, United States
Long Beach Memorial Atlantic
Long Beach, California, United States
Sutter Valley Hospitals Modesto
Modesto, California, United States
Sutter Valley Hospitals PAMF Sutter
Palo Alto, California, United States
Sutter Valley Hospitals Roseville
Roseville, California, United States
Sutter Valley Hospitals Alhambra
Sacramento, California, United States
Sutter Valley Hospitals Capitol Pavilion
Sacramento, California, United States
University of California San Francisco Health System
San Francisco, California, United States
Sutter Valley Hospitals PAMF Santa Cruz
Santa Cruz, California, United States
Sutter Health Santa Rosa
Santa Rosa, California, United States
Sutter Valley Hospitals PAMF Sunnyvale
Sunnyvale, California, United States
Sutter Valley Hospitals Fairfield
Vallejo, California, United States
Morehouse School of Medicine Atlanta
Atlanta, Georgia, United States
Morehouse School of Medicine Lee Street
Atlanta, Georgia, United States
Morehouse School of Medicine Princeton Lakes
Atlanta, Georgia, United States
Morehouse School of Medicine East Point
Atlanta, Georgia, United States
Community Health Network Anderson
Anderson, Indiana, United States
Community Health Network North
Fishers, Indiana, United States
Community Health Network East
Indianapolis, Indiana, United States
Community Health Network South
Indianapolis, Indiana, United States
Community Health Network Kokomo
Kokomo, Indiana, United States
Ochsner Health Bocage
Baton Rouge, Louisiana, United States
Ochsner Health Grove
Baton Rouge, Louisiana, United States
Ochsner Health Covington
Covington, Louisiana, United States
Ochsner Health St. Tammany Parish
Covington, Louisiana, United States
Ochsner Health STCC
Covington, Louisiana, United States
Ochsner Health Kenner
Kenner, Louisiana, United States
Ochsner Health Lafayette
Lafayette, Louisiana, United States
Ochsner Health Westbank
Marrero, Louisiana, United States
Ochsner Health Lafreniere
Metairie, Louisiana, United States
Ochsner Health Benson
New Orleans, Louisiana, United States
Mercy Health - Springfield
Springfield, Missouri, United States
Mercy Health St. Louis
St Louis, Missouri, United States
OHSU CEDAR Clinical Trials Beaverton
Beaverton, Oregon, United States
OHSU CEDAR Clinical Trials Orenco
Hillsboro, Oregon, United States
OHSU CEDAR Clinical Trials Portland
Portland, Oregon, United States
OHSU CEDAR Clinical Trials Richmond
Portland, Oregon, United States
Geisinger Bloomsburg Hospital
Bloomsburg, Pennsylvania, United States
HCA Healthcare Brentwood
Brentwood, Tennessee, United States
HCA Healthcare Centennial
Nashville, Tennessee, United States
HCA Healthcare Nashville
Nashville, Tennessee, United States
West Virginia University Health System
Morgantown, West Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GRAIL-MA-002
Identifier Type: -
Identifier Source: org_study_id
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