Umbrella Study for Single Patient Treatments in Oncology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient-specific treatments.
- Who it may be relevant to
- Registry conditions: Advanced Cancer, Rare Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
UNIQUE: Umbrella N-of-1 Tumor Trials - Umbrella Protocol for Oncology Single Patient Protocols
Overview
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
Interventions
- Other Patient-specific treatments
Treatment will be decided specifically for the patient based on biomarker test results.
Primary outcome measures
- Overall response rate for the overall cohorts and the number of patients accessing precision targeted therapy [Time frame: 3 years]
Secondary outcome measures (3)
- Overall survival rate [Time frame: 5 years]
- Progression-free survival [Time frame: 5 years]
- Number of participants with adverse events as assessed by CTCAE v5.0 [Time frame: 3 years]
Eligibility criteria
Inclusion Criteria \& Exclusion Criteria:
Patient's existing genomic information from tumor molecular profiling will be discussed in the hospital expert molecular tumor board rounds consisting of representatives from specialist genomic profiling and medical oncology departments to decide N of 1 treatment for the patient. The discussion will surround the best next therapeutic option in the patient's cancer subtype with or without clear standard of care guidelines. Therefore, specific eligibility criteria aside from individual patient's medical history is not applicable.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- University Health Network, Princess Margaret Cancer Centre — Toronto
Identifiers
NCT: NCT06285500 · UNIQUE · 23-5095