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 to enroll approximately 20% of the study participants from under-represented minority populations (e.g., racial / ethnic minority groups, socioeconomically disadvantaged populations, rural populations).

Official Title

REACH Study: Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity

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,
  2. * Eligible to receive the Galleri test, based on a determination by the study investigator or designee that the test is clinically appropriate,
  3. * Capable of giving informed consent that is legally effective (consent provided by a legally authorized representative is not permitted in this protocol), and
  4. * Able to comprehend and respond to questions in participant questionnaires. Comprehension level is determined by the study investigator or designee.
  5. * Aged ≥ 50 years with Medicare coverage,
  6. * Have had ≥ 1 UC visit
  1. * Having had a previous Galleri test not associated with this study.
  2. * Undergoing clinical evaluation for symptoms suspicious for cancer.
  3. * 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.
  4. * Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded.
  5. * Prior/Concurrent Concomitant Therapy (Medications/Treatments):
  6. * Definitive treatment for invasive solid tumor or hematologic malignancy within the 3 years prior to expected enrollment date.
  7. * Adjuvant hormone therapy for cancer (i.e., for breast or prostate cancer) is not an exclusion criterion.
  8. * Current pregnancy
  9. * Individuals who will not be able to comply with the protocol procedures.
  10. * Individuals who are not currently registered patients at a participating center.
  11. * Previous or current employees or contractors of GRAIL.
  12. * 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).
  13. * 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.
  14. * Individuals with a diagnosis of non-metastatic basal cell carcinoma and squamous cell carcinoma of the skin are not excluded.
  15. * Prior/Concurrent Concomitant Therapy (Medications/Treatments):
  16. * Definitive treatment for invasive solid tumor or hematologic malignancy within the 3 years prior to expected enrollment date.
  17. * Adjuvant hormone therapy for cancer (e.g. for breast or prostate cancer) is not an exclusion criterion.
  18. * Current pregnancy.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Community Health Network
Indianapolis, Indiana, 46256
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