Collecting data on advanced and rare cancers treated with personalized medicine
UNIQUE: Umbrella N-of-1 Tumor Trials - Umbrella Protocol for Oncology Single Patient Protocols
University Health Network, Toronto · NCT06285500
This study is trying to see how people with advanced and rare cancers respond to personalized treatments when they have run out of other options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06285500 on ClinicalTrials.gov |
What this trial studies
This study aims to gather information on how patients with advanced and rare cancers respond to biomarker-based treatments through a unique umbrella protocol. It focuses on individuals who have exhausted all standard treatment options and are not eligible for ongoing trials. Participants will be assigned to cohorts based on their treatment history, which may include standard care drugs, special access drugs, or investigational agents. Data collected will include demographic information, medical history, cancer characteristics, and treatment responses.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced cancer or rare diseases who have exhausted all standard treatment options.
Not a fit: Patients who are eligible for ongoing clinical trials or have not yet exhausted standard treatment options may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective personalized treatment options for patients with advanced and rare cancers.
How similar studies have performed: Other studies utilizing precision medicine approaches have shown promise, indicating potential for success in this novel framework.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toronto, Ontario
- University Health Network, Princess Margaret Cancer Centre — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Amit Oza, Dr. — University Health Network, Toronto
- Study coordinator: Amit Oza, Dr.
- Email: amit.oza@uhn.ca
- Phone: 416 946 4450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Cancer, Rare Diseases, single patient protocols