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PRecision Oncology Evidence Development in Cancer Treatment - Clinical: PREDiCTc

Cancer

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.

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 and up

Critères de participation

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.

Lieu de l'étude

BC Cancer
BC Cancer
Vancouver, British Columbia
Canada

Contactez l'équipe d'étude

Primary Contact

Cheryl Ho, MD

604-877-6000
Étude parrainée par
British Columbia Cancer Agency
Participants recherchés
Plus d'informations
ID de l'étude: NCT04814095