Genomic Investigation of Unusual Responders (GENIUS)

  • End date
    Nov 5, 2023
  • participants needed
  • sponsor
    University Health Network, Toronto
Updated on 5 May 2022
cancer chemotherapy
therapeutic agents


Studies have shown that tumors from the same patient may respond very differently to the same therapeutic agents. This study aims to investigate the genetic basis of tumors that respond abnormally well or poorly to therapeutic agents in an effort to understand the fundamental genetic basis of this response. The present protocol seeks to retrospectively perform Exome, next-generation (DNA) sequencing and/or other molecular techniques on tumor samples to identify the genetic basis of a patient's exceptional response to chemotherapy.

Condition Cancer, Breast Cancer, Non-small Cell Lung Cancer, Colorectal Cancer, Genitourinary Cancer, Gynecological Cancer, Upper Aerodigestive Tract Cancer, Pancreatobiliary Gastrointestinal Cancer, Melanoma (Skin), Rare Cancer, Carcinoma of Unknown Primary
Clinical Study IdentifierNCT03740503
SponsorUniversity Health Network, Toronto
Last Modified on5 May 2022


Yes No Not Sure

Inclusion Criteria

The patient must have either an exceptionally good or poor response to treatment, as indicated by their treating physician
The exact definition of this is adaptable to the disease but a suggested guideline is a Complete Response, Partial Response or progression free interval of at least 6 months
Exceptionally poor response includes patients who were expected to respond favourably to a treatment but instead responded poorly (e.g dramatic tumor growth or death)
The patient must have sufficient archival tumor available for sequencing
Deceased patients will also be considered for analysis (up to 30 patients per year) if they meet at least one of the following requirements
a)) Patients who have archival tissue stored within the UHN Laboratory
Medicine Program who have had a consent waiver granted by the REB to access
the tissue
Patients who have archival tissue banked for further research within the UHN Biospecimen Sciences Program

Exclusion Criteria

Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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