Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285500
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-07
Brief Title:
Umbrella Study for Single Patient Treatments in Oncology
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
UNIQUE Umbrella N-of-1 Tumor Trials - Umbrella Protocol for Oncology Single Patient Protocols
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UNIQUE
Brief Summary:
The purpose of this study is to collect data on how advanced and rare cancers respond to biomarker-based treatments
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 There is no additional visit or procedure required to participate in this study Participants who have receivedwho may receive the following treatments may join the study and will be assigned to a study cohort group
Group 1 - Health Canada approvedmarketed drugs used on or off-label as 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
Group 1 - Health Canada approvedmarketed drugs used on or off-label as 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 23-5095 | OTHER | University Health Network | None |