Clinical trial · Observational
REFLECTION: A Clinical Practice Learning Program for Galleri®
REFLECTION: Real World Evidence for Learnings in Early Cancer Detection, a Clinical Practice Learning Program for Galleri®
NCT05205967CI-TRIAL-00097975active not recruitingClinicalTrials.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)
REFLECTION is a multi-center, prospective, non-interventional, cohort study that will enroll approximately 14,000 individuals who have opted to be screened with Galleri®, a blood-based, multi-cancer early detection (MCED) test in routine clinical settings. The purpose of the study is to understand the real-world experience of Galleri® in clinical settings.
Conditions
Conditions (2)
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 |
| Early Detection of Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MCED | Other | — | UNRESOLVED |
| SOC | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients who received the Galleri® test.
- interventionNames
- Other: MCED
- Other: SOC
Primary outcomes (1)
- measure
- To describe signal detection and cancer detection within and across sites among participants who opt to receive Galleri® in a real world setting.
- timeFrame
- Up to 12 Months
Secondary outcomes (2)
- measure
- Galleri®: To assess the feasibility and acceptability of Galleri® from the perspective of participants and patient-reported outcomes (PROs) in a real-world setting.
- timeFrame
- Up to 12 Months
- measure
- HCRU: To assess healthcare resource utilization (HCRU) associated with cancer diagnostic workups for participants with signal detected Galleri® test results.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participant has the ability to understand and the willingness to sign a written informed consent form (ICF); * Participant is at least 22 years old at the time of consent; * A provider or their designee has ordered the Galleri® test; and * Participant has the ability to comprehend the participant questionnaires. Exclusion Criteria: * There are no exclusions
References
Publications (1)
- DERIVEDKortlever TL, Ferlizza E, Lauriola M, Borrelli F, Porro A, Spaander MCW, Bossuyt PM, Ricciardiello L, Dekker E. Diagnostic Accuracy of an Add-On, Blood-Based Screening Test for Colorectal Cancer in Two Established Screening Programmes. Aliment Pharmacol Ther. 2025 Jun;61(12):1935-1943. doi: 10.1111/apt.70141. Epub 2025 Apr 10. PMID 40207404