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Trial Title:
Umbrella Study for Single Patient Treatments in Oncology
NCT ID:
NCT06285500
Condition:
Advanced Cancer
Rare Diseases
Conditions: Official terms:
Rare Diseases
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
Patient-specific treatments
Description:
Treatment will be decided specifically for the patient based on biomarker test results.
Arm group label:
Group 1
Arm group label:
Group 2
Arm group label:
Group 3
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
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 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
Criteria for eligibility:
Study pop:
Patients have advanced and rare cancer with limited treatment options.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Health Network, Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Amit Oza, Dr.
Phone:
416 946 4450
Email:
amit.oza@uhn.ca
Start date:
February 1, 2024
Completion date:
February 1, 2029
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06285500
