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Umbrella Study for Single Patient Treatments in Oncology

NCT ID: NCT06285500

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2029-02-01

Brief Summary

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

Detailed Description

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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

Conditions

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Advanced Cancer Rare Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Group 1

N-of-1 treatment with marketed drugs used on or off-label as per SOC.

Patient-specific treatments

Intervention Type OTHER

Treatment will be decided specifically for the patient based on biomarker test results.

Group 2

N-of-1 treatment with drugs accessed from SAP.

Patient-specific treatments

Intervention Type OTHER

Treatment will be decided specifically for the patient based on biomarker test results.

Group 3

N-of-1 treatment with non-marketed investigational agents.

Patient-specific treatments

Intervention Type OTHER

Treatment will be decided specifically for the patient based on biomarker test results.

Interventions

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Patient-specific treatments

Treatment will be decided specifically for the patient based on biomarker test results.

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amit Oza, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Amit Oza, Dr.

Role: CONTACT

Phone: 416 946 4450

Email: [email protected]

Facility Contacts

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Amit Oza, Dr.

Role: primary

Other Identifiers

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23-5095

Identifier Type: OTHER

Identifier Source: secondary_id

UNIQUE

Identifier Type: -

Identifier Source: org_study_id