Thinking of joining a study?

Register your interest

NCT06285500 | RECRUITING | Advanced Cancer


Umbrella Study for Single Patient Treatments in Oncology
Sponsor:

University Health Network, Toronto

Brief Summary:

The purpose of this study is to collect data on how advanced and rare cancers respond to biomarker-based treatments.

Condition or disease

Advanced Cancer

Rare Diseases

Intervention/treatment

Patient-specific 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

Study Type : OBSERVATIONAL
Estimated Enrollment : 400 participants
Official Title : UNIQUE: Umbrella N-of-1 Tumor Trials - Umbrella Protocol for Oncology Single Patient Protocols
Actual Study Start Date : 2024-02-01
Estimated Primary Completion Date : 2027-02-01
Estimated Study Completion Date : 2029-02-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

Umbrella Study for Single Patient Treatments in Oncology

Location Details

NCT06285500


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

Canada, Ontario

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Loading...