Evidence Development in Cancer Treatment - Real World: PREDiCTrw

September 22, 2025 updated by: British Columbia Cancer Agency
This pilot clinical trial aims to assess the real world quality of life and survival of patients treated with therapy that has preliminary evidence of efficacy but uncertainty of the magnitude of clinical benefit or cost effectiveness in subjects with cancer. The goal of this study is to collect real world evidence with respect to quality of life and outcomes to support decision making.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Clinical practice involves incorporating new data into treatment recommendations including non randomized phase I/II studies. Clinicians' decision-making is swayed by alternative endpoints like response rate (RR), depth of response and progression free survival (PFS), presumed to be surrogates for overall survival (OS). Determination of the added value of these new therapies in terms of outcomes and quality of life (QOL) is challenging in the absence of comparators in trials resulting in increased uncertainty in terms of outcomes, quality of life and cost-effectiveness.

With the possibility of a randomized clinical trial evidence being low in certain populations, the use of real world data (RWD) can provide information regarding therapies with preliminary evidence of efficacy but uncertainty of the magnitude of clinical benefit or cost effectiveness. With RWD, patients may receive access to therapies and participate in the evidence generation package.

This study proposes to use RWD to generate evidence to evaluate therapies with preliminary evidence of efficacy but uncertainty of the magnitude of clinical benefit or cost effectiveness. The key components include regular interval disease assessments (eg radiographic imaging) and collection of patient reported outcomes (PROs) using standardized QOL questionnaires. The aim is to provide high quality real world evidence (RWE) for assessment and economic modelling to reduce uncertainty and facilitate decision-making.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z4E6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects with cancer for which there remains ongoing questions regarding clinical effectiveness and/or cost effectiveness regarding a therapeutic agent
  • Eastern Co-operative Group (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
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than 1% per year during the treatment period and for at least 5 months after the last dose.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse with a female partner of childbearing potential or who is pregnant) or use contraceptive measures, and agreement to refrain from donating sperm, during the treatment period and for at least 5 months after the last dose.
  • 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
  • Pregnancy or breastfeeding.
  • Any significant cardiovascular disease, comorbidity (i.e. recent major infection, HIV, tuberculosis) or major surgical procedure within 21 days that in the opinion of the investigator renders the proposed treatment unsafe.
  • Subjects who are otherwise felt by the treating clinician to be unfit to proceed with this protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapy
Regular disease assessment (eg radiographic imaging) and quality of life (QOL) questionnaires
Diagnostic test: Radiographic or laboratory evaluation
Radiographic or laboratory evaluation every 12 weeks +/- 2 weeks
Behavioral: QOL - quality of life
QOL assessments using EQ5D (Euroqol 5 dimension) +/- ESAS (Edmonton Symptom Assessment Scale) +/- CPC (Canadian Problem Checklist) every 4-8 weeks +/- 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
Overall survival from initiation of therapy
From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
Response rate as defined by standard measurement for tumor site (eg RECIST 1.1)
From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
Progression/event free survival
Time Frame: From date of initiation until the date of progression or date of death from any cause, whichever came first, assessed up to 100 months
Progression or event free survival from initiation of therapy
From date of initiation until the date of progression or date of death from any cause, whichever came first, assessed up to 100 months
Quality adjust survival
Time Frame: From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
Quality adjusted survival from initiation of therapy
From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
Physician assessed response rate
Time Frame: From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
Response rate as defined by physician assessed response
From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
Quality of life assessments
Time Frame: From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
Quality of life assessments using EQ5D scale 1 to 5 with 5 being extreme problems
From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

British Columbia Cancer Agency

Investigators

  • Study Chair: Cheryl Ho, MD, BC Cancer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREDiCTrw

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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