NCT06285500

Umbrella Study for Single Patient Treatments in Oncology

UNIQUE: Umbrella N-of-1 Tumor Trials - Umbrella Protocol for Oncology Single Patient Protocols

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect data for assessing the improvement of the overall response rate for the overall cohorts and the proportion of patients accessing precision targeted therapy.

Detailed description

The UNIQUE umbrella protocol is an overarching framework to study precision medicine in patients with precise molecular data, who have exhausted all established treatment options and who are not eligible for any of the ongoing trials. Participants who have received/who may receive the following treatments may join the study and will be assigned to a study cohort (group): * Group 1 - Health Canada approved/marketed drug(s) used on or off-label as per Standard of Care (SOC) * Group 2 - Drugs accessed from Special Access Program (SAP) * Group 3 - Non-marketed investigational agents Under the UNIQUE framework, data from participants will be evaluated. The following data will be collected: * Demographic data (for example: sex, race, month and year of birth) * Medical history * Cancer characteristics including biomarkers * Treatment history * response to treatment

Conditions

• Advanced Cancer
• Rare Diseases

Interventions

Type	Name	Description
OTHER	Patient-specific treatments	Treatment will be decided specifically for the patient based on biomarker test results.

Timeline

• Start date: 2024-02-01
• Primary completion: 2027-02-01
• Completion: 2029-02-01
• First posted: 2024-02-29
• Last updated: 2025-12-16

Locations

1 site across 1 country: Canada