Recruiting

Observational Study

Sponsor:

British Columbia Cancer Agency

Code:

NCT06242912

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

QOL - quality of life

Radiographic or laboratory evaluation

Study Details

Brief summary:

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.

Conditions

Cancer

Study ID

NCT06242912

Start date

Jan 22, 2024

Status verified date

Sep, 2025

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Therapy

Regular disease assessment (eg radiographic imaging) and quality of life (QOL) questionnaires

Interventions

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

Radiographic or laboratory evaluation

Radiographic or laboratory evaluation every 12 weeks +/- 2 weeks

Primary outcome measure

  • Overall survival [ Time Frame: From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months ]

Central Contacts and Locations

Central contacts

Cheryl Ho, MD

604 877 6000cho@bccancer.bc.ca

Howard Lim, MD

604 877 6000hlim@bccancer.bc.ca

Locations

BC Cancer

Recruiting

Vancouver, British Columbia, Canada, V5Z4E6

Contacts

Fatima Usman

604 877 6000fatima.usman1@bccancer.bc.ca

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2025-09-25.