NCT04814095 PRecision Oncology Evidence Development in Cancer Treatment - Clinical: PREDiCTc
| NCT ID | NCT04814095 |
| Status | Recruiting |
| Phase | — |
| Sponsor | British Columbia Cancer Agency |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-06-30 |
| Primary Completion | 2028-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2021-06-30 with a primary completion date of 2028-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Cheryl Ho, MD
PRINCIPAL INVESTIGATOR
BC Cancer
Frequently Asked Questions
Who can join the NCT04814095 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04814095 currently recruiting?
Yes, NCT04814095 is actively recruiting participants. Contact the research team at spollard@bccrc.ca for enrollment information.
Where is the NCT04814095 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT04814095 clinical trial?
NCT04814095 is sponsored by British Columbia Cancer Agency. The principal investigator is Cheryl Ho, MD at BC Cancer. The trial plans to enroll 30 participants.
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