PRecision Oncology Evidence Development in Cancer Treatment - Clinical: PREDiCTc

NCT04814095 | Recruiting

• 1 other identifier: PREDiCTc
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall survival from initiation of targeted therapy

  Baseline until death up to 5 years

Secondary Outcomes (5)

• Response rate as defined by RECIST 1.1

  Baseline until progression up to 5 years

• Response rate as defined by physician assessed response

  Baseline until progression up to 5 years

• Progression free survival (PFS) from initiation of targeted therapy

  Baseline until progression up to 5 years

• Quality of life (QoL) assessments using the EQ-5D every 8 weeks from initiation of targeted therapy

  Baseline until death up to 5 years

• Quality adjusted survival from initiation of targeted therapy

  Baseline until death up to 5 years

Study Arms (1)

Targeted therapy

EXPERIMENTAL

Behavioral: QOL; Diagnostic Test: CT imaging

Interventions

QOL BEHAVIORAL

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

Targeted therapy

CT imaging DIAGNOSTIC_TEST

CT radiographic imaging every 12 weeks +/- 2 weeks

Targeted therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5Z4E6, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Postmortem Imaging

Intervention Hierarchy (Ancestors)

Autopsy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Investigative Techniques

Study Officials

• Cheryl Ho, MD

  BC Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Pollard, PhD

CONTACT

604-675-8000; spollard@bccrc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: March 24, 2021
• Study Start: June 30, 2021
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)