Clinical trial · Interventional
Galleri® in the Medicare Population.
REACH Study: Galleri® in the Medicare Population.
NCT05673018CI-TRIAL-00112495recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-Cancer Early Detection Test (Galleri®) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- (Galleri + UC)
- description
- Medicare beneficiaries who receive the Galleri test plus usual care (Galleri + UC).
- interventionNames
- Device: Multi-Cancer Early Detection Test (Galleri®)
- type
- NO_INTERVENTION
- label
- (UC) alone
- description
- Passively-enrolled Contemporaneous Comparator Arm of Medicare beneficiaries who receive usual care (UC) alone.
Primary outcomes (1)
- measure
- Incidence rates of stage IV cancers
- timeFrame
- Up to 3 Years
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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): 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.
References
Publications (0)
Data not yet available
No reference posted for this study.