- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04814095
PRecision Oncology Evidence Development in Cancer Treatment - Clinical: PREDiCTc (PREDiCTc)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In Canada, adoption of new systemic therapies for cancer treatment is a multi-step process. After completion of clinical trials, pharmaceutical companies submit a request for a new drug approval to Health Canada. Therapies undergo rigorous review at Health Canada to confirm safety and efficacy before a Notice of Compliance (NOC) or NOC conditional (NOC/c) is issued that allows sale of the new medication in Canada. An additional layer of evaluation, a health technology assessment (HTA), is undertaken through the pan Canadian Oncology Drug Review (pCODR). A positive recommendation from pCODR is required for national price negotiations through the pan Canadian Pharmaceutical Alliance (pCPA). Once this step is completed, provincial pharmacies establish local contracts to permit local implementation of the new therapy.
As our understanding of pathogenesis evolves and next generation sequencing becomes more affordable, rare molecular entities amenable to treatment with targeted or selected therapies, like immunotherapy, are being increasingly identified. These molecular aberrations can occur with frequencies of 1-2% making it unfeasible to conduct large randomized trials to establish benefit. Determination of the added value of these new therapies in terms of outcomes and quality of life is challenging in the absence of comparators in trials resulting in increased uncertainty in terms of outcomes, quality of life (QOL) and cost-effectiveness. To address the uncertainty, pharmaceutical companies and the pCODR economic guidance panel create economic models with sensitivity analyses to try to estimate the cost-effectiveness of therapy. These models however, are dependent on the nature and quality of available data.
This study proposes to use real world data to generate evidence to assist in evaluate new therapies in rare molecular entities. The key components include regular interval radiographic imaging and collection of patient reported outcomes using standardized QOL questionnaires. The aim is to provide high quality real world evidence for assessment and economic modelling to reduce uncertainty and facilitate HTA decision-making.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z4E6
- Recruiting
- BC Cancer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject age greater than or equal to 18 years at the time of signature of informed consent.
- Subjects with an incurable malignancy who have been identified to have a rare cancer or rare molecular aberration who is currently receiving Health Canada approved targeted therapy that is not nationally funded
- ECOG 0-2
- Life expectancy of at least 12 weeks
- Adequate hematologic and end organ function for drug treatment per the clinician's assessment
- Asymptomatic or treated brain metastases permitted
- Ability to give informed consent for the study procedures defined in this protocol.
Exclusion Criteria:
- Treatment with any approved or investigational agent or participation in another clinical trial with therapeutic intent within 14 days prior to enrollment.
- Inability to complete quality of life questionnaires
- Subjects who are felt by the treating clinician to be unfit to proceed with this protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Targeted therapy
|
QOL assessments using the ESAS, CPC, EQ5D every 4-8 weeks +/- 2 weeks
CT radiographic imaging every 12 weeks +/- 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival from initiation of targeted therapy
Time Frame: Baseline until death up to 5 years
|
Baseline until death up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate as defined by RECIST 1.1
Time Frame: Baseline until progression up to 5 years
|
Baseline until progression up to 5 years
|
Response rate as defined by physician assessed response
Time Frame: Baseline until progression up to 5 years
|
Baseline until progression up to 5 years
|
Progression free survival (PFS) from initiation of targeted therapy
Time Frame: Baseline until progression up to 5 years
|
Baseline until progression up to 5 years
|
Quality of life (QoL) assessments using the EQ-5D every 8 weeks from initiation of targeted therapy
Time Frame: Baseline until death up to 5 years
|
Baseline until death up to 5 years
|
Quality adjusted survival from initiation of targeted therapy
Time Frame: Baseline until death up to 5 years
|
Baseline until death up to 5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PREDiCTc
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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