RECRUITING

Galleri® in the Medicare Population.

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Conditions

CancerctDNA, Circulating tumor DNA, Screening, Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

REACH Study: Galleri® in the Medicare Population.

Quick Facts

Study Start:2024-07-12
Study Completion:2030-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05673018

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged ≥50 years with Medicare coverage, including Traditional Medicare (Part A \& B or Dual Eligibles) or Medicare Advantage.
  2. * Capable of giving informed consent that is legally effective (consent provided by a legally authorized representative is not permitted in this protocol).
  3. * Aged ≥ 50 years with Medicare coverage, including Traditional Medicare (Part A \& B or Dual Eligibles) or Medicare Advantage.
  4. * Have had ≥ 1 UC visit
  1. * 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.
  2. * 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):
  3. 1. Diagnosed ≤3 years before expected enrollment date and/or
  4. 2. Diagnosed \>3 years before expected enrollment date and never treated and/or
  5. 3. Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).
  6. * Current pregnancy.
  7. * Individuals who are currently inpatients at a participating site.
  8. * Individuals who are not willing or able to comply with the protocol procedures.
  9. * Individuals who are not currently registered patients at a participating center.
  10. * Previous or current employees or contractors of GRAIL.
  11. * 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.
  12. * Undergoing clinical evaluation for suspicion of cancer.
  13. * Personal history of hematologic malignancy and/or invasive solid tumor (not including non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin):
  14. 1. Diagnosed ≤3 years before expected enrollment date and/or
  15. 2. Diagnosed \>3 years before expected enrollment date and never treated and/or
  16. 3. Currently undergoing active cancer management (not including adjuvant hormone therapy for breast or prostate cancer).
  17. * Current pregnancy.
  18. * Individuals who are currently inpatients at a participating site.

Contacts and Locations

Study Contact

GRAIL Medical Information
CONTACT
833-694-2553
customerservice@grail.com

Study Locations (Sites)

Sutter Valley Hospitals Auburn
Auburn, California, 95603
United States
Sutter Valley Hospitals Davis
Davis, California, 95616
United States
Sutter Valley Hospitals Elk Grove
Elk Grove, California, 95758
United States
Long Beach Memorial Orange Coast
Fountain Valley, California, 92708
United States
Long Beach Memorial Saddleback
Laguna Hills, California, 92653
United States
Long Beach Memorial Atlantic
Long Beach, California, 90806
United States
Sutter Valley Hospitals Modesto
Modesto, California, 95355
United States
Sutter Valley Hospitals PAMF Sutter
Palo Alto, California, 94301
United States
Sutter Valley Hospitals Roseville
Roseville, California, 95661
United States
Sutter Valley Hospitals Alhambra
Sacramento, California, 95816
United States
Sutter Valley Hospitals Capitol Pavilion
Sacramento, California, 95816
United States
University of California San Francisco Health System
San Francisco, California, 94158
United States
Sutter Valley Hospitals PAMF Santa Cruz
Santa Cruz, California, 95065
United States
Sutter Health Santa Rosa
Santa Rosa, California, 95403
United States
Sutter Valley Hospitals PAMF Sunnyvale
Sunnyvale, California, 94086
United States
Sutter Valley Hospitals Fairfield
Vallejo, California, 94589
United States
Morehouse School of Medicine Atlanta
Atlanta, Georgia, 30303
United States
Morehouse School of Medicine Lee Street
Atlanta, Georgia, 30310
United States
Morehouse School of Medicine Princeton Lakes
Atlanta, Georgia, 30331
United States
Morehouse School of Medicine East Point
Atlanta, Georgia, 30344
United States
Community Health Network Anderson
Anderson, Indiana, 46011
United States
Community Health Network North
Fishers, Indiana, 46038
United States
Community Health Network East
Indianapolis, Indiana, 46219
United States
Community Health Network South
Indianapolis, Indiana, 46256
United States
Community Health Network Kokomo
Kokomo, Indiana, 46902
United States
Ochsner Health Bocage
Baton Rouge, Louisiana, 70809
United States
Ochsner Health Grove
Baton Rouge, Louisiana, 70836
United States
Ochsner Health Covington
Covington, Louisiana, 70433
United States
Ochsner Health St. Tammany Parish
Covington, Louisiana, 70433
United States
Ochsner Health STCC
Covington, Louisiana, 70433
United States
Ochsner Health Kenner
Kenner, Louisiana, 70065
United States
Ochsner Health Lafayette
Lafayette, Louisiana, 70503
United States
Ochsner Health Westbank
Marrero, Louisiana, 70072
United States
Ochsner Health Lafreniere
Metairie, Louisiana, 70003
United States
Ochsner Health Benson
New Orleans, Louisiana, 70121
United States
Mercy Health - Springfield
Springfield, Missouri, 65807
United States
Mercy Health St. Louis
St Louis, Missouri, 63141
United States
OHSU CEDAR Clinical Trials Beaverton
Beaverton, Oregon, 97006
United States
OHSU CEDAR Clinical Trials Orenco
Hillsboro, Oregon, 97124
United States
OHSU CEDAR Clinical Trials Portland
Portland, Oregon, 97201
United States
OHSU CEDAR Clinical Trials Richmond
Portland, Oregon, 97202
United States
Geisinger Bloomsburg Hospital
Bloomsburg, Pennsylvania, 17815
United States
HCA Healthcare Brentwood
Brentwood, Tennessee, 37027
United States
HCA Healthcare Centennial
Nashville, Tennessee, 37203
United States
HCA Healthcare Nashville
Nashville, Tennessee, 37203
United States
West Virginia University Health System
Morgantown, West Virginia, 26501
United States

Collaborators and Investigators

Sponsor: GRAIL, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-12
Study Completion Date2030-09

Study Record Updates

Study Start Date2024-07-12
Study Completion Date2030-09

Terms related to this study

Keywords Provided by Researchers

  • ctDNA, Circulating tumor DNA, Screening, Cancer

Additional Relevant MeSH Terms

  • Cancer