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RECRUITING Not applicable ClinicalTrials.gov

Evidence Development in Cancer Treatment - Real World: PREDiCTrw

Sponsor: British Columbia Cancer Agency • ClinicalTrials.gov ID: NCT06242912

Registry updated: 2026-10-19
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Description

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.

Interventions

  • QOL - quality of life (Behavioral)
    QOL assessments using EQ5D (Euroqol 5 dimension) +/- ESAS (Edmonton Symptom Assessment Scale) +/- CPC (Canadian Problem Checklist) every 4-8 weeks +/- 2 weeks
  • Radiographic or laboratory evaluation (Diagnostic test)
    Radiographic or laboratory evaluation every 12 weeks +/- 2 weeks

Eligibility criteria

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.

Conditions

Cancer

Locations

  • BC Cancer — Vancouver, British Columbia, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record