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Genomic Investigation of Unusual Responders (GENIUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03740503
Recruitment Status : Active, not recruiting
First Posted : November 14, 2018
Last Update Posted : April 6, 2020
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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 or disease
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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genomic Investigation of Unusual Responders
Actual Study Start Date : November 1, 2013
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Genomic Characterization of Tumor Samples [ Time Frame: Through study completion, up to 2 years ]
    Characterization of the genetic changes that may explain a tumor's exceptional response or disaster to therapeutc agents.

Biospecimen Retention:   Samples With DNA
Archival tumor tissue, whole blood at baseline for germ-line DNA analysis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled who displayed exceptional response as well as those who were expected to respond favourably but displayed a poor outcome (e.g. drastic tumour growth or death) to their prescribed medication or treatment from a clinical trial.

Inclusion Criteria:

  1. The patient must have either an exceptionally good or poor response to treatment, as indicated by their treating physician.

    1. 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
    2. 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)
  2. The patient must have sufficient archival tumor available for sequencing.
  3. 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.

    b) Patients who have archival tissue banked for further research within the UHN Biospecimen Sciences Program

    Exclusion Criteria:

    • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03740503

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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: David Cescon, MD Princess Margaret Cancer Centre
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Responsible Party: University Health Network, Toronto Identifier: NCT03740503    
Other Study ID Numbers: GENIUS
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Breast Cancer
Non- small Cell Lung Cancer
Colorectal Cancer
Genitourinary Cancer
Gynecological Cancer
Upper Aerodigestive Tract Cancer
Pancreatobiliary Gastrointestinal Cancer
Melanoma Cancer
Rare Cancer
Unknown Primary Cancer
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Gastrointestinal Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases