Recruiting

PREDiCTc

Sponsor:

British Columbia Cancer Agency

Code:

NCT04814095

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

QOL

CT imaging

Study Details

Brief summary:

This pilot clinical trial aims to assess the real world quality of life and survival of patients treated with targeted therapy that has preliminary evidence of efficacy in subjects with advanced rare cancers or cancer harbouring rare molecular aberrations. The treatment has been granted conditional or full approved by Health Canada (HC) as effective and safe. Due to the rarity of the cancer or molecular aberration the uncertainty level of the health technology assessment (HTA) by the pan Canadian Oncology Review (pCODR) was too high for consideration of funding or it was not submitted for consideration. Consequently, the goal of this study is to generate real world evidence to support HTA decision making throughout the life cycle of the product.

Conditions

Cancer

Study ID

NCT04814095

Start date

Jun 30, 2021

Status verified date

Oct, 2026

Completion date

May 1, 2028

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Targeted therapy

Interventions

QOL

QOL assessments using the ESAS, CPC, EQ5D every 4-8 weeks +/- 2 weeks

CT imaging

CT radiographic imaging every 12 weeks +/- 2 weeks

Primary outcome measure

  • Overall survival from initiation of targeted therapy [ Time Frame: Baseline until death up to 5 years ]

Central Contacts and Locations

Central contacts

Samantha Pollard, PhD

604-675-8000spollard@bccrc.ca

Locations

BC Cancer

Recruiting

Vancouver, British Columbia, Canada, V5Z4E6

Contacts

Cheryl Ho, MD

604-877-6000

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Keywords

  • targeted therapy
  • health technology assessment
  • real world evidence
  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.