Galleri® in the Medicare Population.
GRAIL, Inc. · NCT05673018
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 50+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 50000
- US sites recruiting
- 71
- Study start
- July 12, 2024
- Record last updated
- October 19, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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 enrollment that is representative of the Medicare population.
Being studied: Multi-Cancer Early Detection Test (Galleri®)
Conditions: Cancer
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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, 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
For Galleri + UC (Galleri-Tested Arm):
- 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):
- Diagnosed ≤3 years before expected enrollment date and/or
- Diagnosed >3 years before expected enrollment date and never treated and/or
- 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):
- Diagnosed ≤3 years before expected enrollment date and/or
- Diagnosed >3 years before expected enrollment date and never treated and/or
- 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.
Recruiting US locations
Mercy Health - Fort Smith
Fort Smith, AR 72903
Site contact: Damon Broyles · MercyResearchREACHStudy@Mercy.net
Sutter Valley Hospitals Auburn
Auburn, CA 95603
Site contact: Kristina A Teresinski · 279-800-9026 · clinicalresearch@sutterhealth.org
Sutter Valley Hospitals Davis
Davis, CA 95616
Site contact: Kristina A Teresinski · 279-800-9026 · clinicalresearch@sutterhealth.org
Sutter Valley Hospitals Elk Grove
Elk Grove, CA 95758
Site contact: Kristina A Teresinski · 279-800-9026 · clinicalresearch@sutterhealth.org
Long Beach Memorial Orange Coast
Fountain Valley, CA 92708
Site contact: Ana Fuentes · 562-760-6849 · Afuentes1@memorialcare.org
Long Beach Memorial Saddleback
Laguna Hills, CA 92653
Site contact: Ana Fuentes · 562-760-6849 · Afuentes1@memorialcare.org
Long Beach Memorial Atlantic
Long Beach, CA 90806
Site contact: Ana Fuentes · 562-760-6849 · Afuentes1@memorialcare.org
Sutter Valley Hospitals Modesto
Modesto, CA 95355
Site contact: Kristina A Teresinski · 279-800-9026 · clinicalresearch@sutterhealth.org
Sutter Valley Hospitals PAMF Sutter
Palo Alto, CA 94301
Site contact: Kristina A Teresinski · 279-800-9026 · clinicalresearch@sutterhealth.org
Sutter Valley Hospitals Roseville
Roseville, CA 95661
Site contact: Kristina A Teresinski · 279-800-9026 · clinicalresearch@sutterhealth.org
Sutter Valley Hospitals Alhambra
Sacramento, CA 95816
Site contact: Kristina A Teresinski · 279-800-9026 · clinicalresearch@sutterhealth.org
Sutter Valley Hospitals Capitol Pavilion
Sacramento, CA 95816
Site contact: Kristina A Teresinski · 279-800-9026 · clinicalresearch@sutterhealth.org
University of California San Francisco Health System
San Francisco, CA 94158
Site contact: Corinne Sears · 415-205-0182 · REACHMCD@ucsf.edu
Sutter Valley Hospitals Santa Barbara
Santa Barbara, CA 93105
Site contact: Kristina Teresinski · 279-800-9026 · clinicalresearch@sutterhealth.org
Sutter Valley Hospitals PAMF Santa Cruz
Santa Cruz, CA 95065
Site contact: Kristina A Teresinski · 279-800-9026 · clinicalresearch@sutterhealth.org
Sutter Health Santa Rosa
Santa Rosa, CA 95403
Site contact: Kristina A Teresinski · 279-800-9026 · clinicalresearch@sutterhealth.org
Sutter Valley Hospitals PAMF Sunnyvale
Sunnyvale, CA 94086
Site contact: Kristina A Teresinski · 279-800-9026 · clinicalresearch@sutterhealth.org
Sutter Valley Hospitals Fairfield
Vallejo, CA 94589
Site contact: Kristina A Teresinski · 279-800-9026 · clinicalresearch@sutterhealth.org
USF Morsani Center for Advanced Healthcare
Tampa, FL 33612
Site contact: Dusan Nikolic · clinicalresearch@usf.edu
Morehouse School of Medicine Atlanta
Atlanta, GA 30303
Site contact: LaTrisha Horne · 404-789-3825 · lhorne@msm.edu
Morehouse School of Medicine Lee Street
Atlanta, GA 30310
Site contact: LaTrisha Horne · 404-789-3825 · lhorne@msm.edu
Morehouse School of Medicine Princeton Lakes
Atlanta, GA 30331
Site contact: LaTrisha Horne · 404-789-3825 · lhorne@msm.edu
Morehouse School of Medicine East Point
Atlanta, GA 30344
Site contact: LaTrisha Horne · 404-789-3825 · lhorne@msm.edu
HCA Healthcare Doctors Hospital
Augusta, GA 30909
Site contact: Kellie Graves · 615-507-2247 · Kellie.Graves@hcahealthcare.com
Community Health Network Anderson
Anderson, IN 46011
Site contact: Allison Landis · 317-621-7724 · Alandis@ecommunity.com
Community Health Network North
Fishers, IN 46038
Site contact: Allison Landis · 317-621-7724 · Alandis@ecommunity.com
Community Health Network East
Indianapolis, IN 46219
Site contact: Allison Landis · 317-621-7724 · Alandis@ecommunity.com
Community Health Network South
Indianapolis, IN 46237
Site contact: Allison Landis · 317-621-7724 · Alandis@ecommunity.com
Community Health Network Kokomo
Kokomo, IN 46902
Site contact: Allison Landis · 317-621-7724 · Alandis@ecommunity.com
Ochsner Health Bocage
Baton Rouge, LA 70809
Site contact: Ellen Lovell · 504-842-8196 · Ellen.Lovell@Ochsner.org
Ochsner Health Grove
Baton Rouge, LA 70836
Site contact: Ellen Lovell · 504-842-8196 · Ellen.Lovell@Ochsner.org
Ochsner Health Covington
Covington, LA 70433
Site contact: Ellen Lovell · 504-842-8196 · Ellen.Lovell@Ochsner.org
Ochsner Health St. Tammany Parish
Covington, LA 70433
Site contact: Ellen Lovell · 504-842-8196 · Ellen.Lovell@Ochsner.org
Ochsner Health STCC
Covington, LA 70433
Site contact: Ellen Lovell · 504-842-8196 · Ellen.Lovell@Ochsner.org
Ochsner Health Kenner
Kenner, LA 70065
Site contact: Ellen Lovell · 504-842-8196 · Ellen.Lovell@Ochsner.org
Ochsner Health Lafayette
Lafayette, LA 70503
Site contact: Ellen Lovell · 504-842-8196 · Ellen.Lovell@Ochsner.org
Ochsner Health Westbank
Marrero, LA 70072
Site contact: Ellen Lovell · 504-842-8196 · Ellen.Lovell@Ochsner.org
Ochsner Health Lafreniere
Metairie, LA 70003
Site contact: Ellen Lovell · 504-842-8196 · Ellen.Lovell@Ochsner.org
Ochsner Health Benson
New Orleans, LA 70121
Site contact: Ellen Lovell · 504-842-8196 · Ellen.Lovell@Ochsner.org
Mercy Health - Joplin
Joplin, MO 64804
Site contact: Damon Broyles · MercyResearchREACHStudy@Mercy.net
Mercy Health - Springfield
Springfield, MO 65807
Site contact: Damon Broyles · MercyResearchREACHStudy@Mercy.net
Mercy Health St. Louis
St Louis, MO 63141
Site contact: Damon Broyles · MercyResearchREACHStudy@Mercy.net
Mercy Health - OKC
Oklahoma City, OK 73120
Site contact: Damon Broyles · MercyResearchREACHStudy@Mercy.net
OHSU CEDAR Clinical Trials Columbia
Astoria, OR 97103
Site contact: Laura Ferrara · 541-645-3276 · REACH@ohsu.edu
OHSU CEDAR Clinical Trials Exchange
Astoria, OR 97103
Site contact: Laura Ferrara · 541-645-3276 · REACH@ohsu.edu
OHSU CEDAR Clinical Trials Beaverton
Beaverton, OR 97006
Site contact: Diana Potts · 503-418-8150 · REACH@ohsu.edu
OHSU CEDAR Clinical Trials BAH
Coos Bay, OR 97420
Site contact: Diana Potts · 503-418-8150 · REACH@ohsu.edu
OHSU CEDAR Clinical Trials Orenco
Hillsboro, OR 97124
Site contact: Diana Potts · 503-418-8150 · REACH@ohsu.edu
OHSU CEDAR Clinical Trials Woods
Hood River, OR 97031
Site contact: Laura Ferrara · 541-645-3276 · REACH@ohsu.edu
OHSU CEDAR Clinical Trials Portland
Portland, OR 97201
Site contact: Diana Potts · 503-418-8150 · REACH@ohsu.edu
OHSU CEDAR Clinical Trials Richmond
Portland, OR 97202
Site contact: Diana Potts · 503-418-8150 · REACH@ohsu.edu
OHSU CEDAR Clinical Trials Adventist
The Dalles, OR 97058
Site contact: Laura Ferrara · 541-645-3276 · REACHstudy@ohsu.edu
OHSU CEDAR Clinical Trials Dalles
The Dalles, OR 97058
Site contact: Laura Ferrara · 541-645-3276 · REACH@ohsu.edu
OHSU CEDAR Clinical Trials Ensign
Warrenton, OR 97146
Site contact: Laura Ferrara · 541-645-3276 · REACH@ohsu.edu
Geisinger Bloomsburg Hospital - Bloomsburg
Bloomsburg, PA 17815
Site contact: Ashley Honushefsky · 570-293-7170 · reachstudy@geisinger.edu
FCCC - East Norriton
East Norriton, PA 19401
Site contact: Camille Ragin · 267-566-3130 · Camlle.ragin@fccc.edu
FCCC - Buckingham
Furlong, PA 18925
Site contact: Camille Ragin · 267-566-3130 · Camlle.ragin@fccc.edu
FCCC - Fox Chase Cancer Center
Philadelphia, PA 19111
Site contact: Camille Ragin · 267-566-3130 · Camlle.ragin@fccc.edu
FCCC - Jeanes
Philadelphia, PA 19111
Site contact: Camille Ragin · 267-566-3130 · Camlle.ragin@fccc.edu
FCCC - Chestnut Hill
Philadelphia, PA 19118
Site contact: Camille Ragin · 267-566-3130 · Camlle.ragin@fccc.edu
+ 11 more on the official record.
Study contacts (from the official record)
- GRAIL Medical Information · 833-694-2553 · customerservice@grail.com
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