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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03740503
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : December 6, 2023
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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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

Study Design
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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 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Groups and Cohorts
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Outcome Measures
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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

Eligibility Criteria
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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.
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03740503


Contacts
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Contact: Celeste Yu 416-946-4501 ext 5281 celeste.yu@uhn.ca
Contact: Elizabeth Shah 416-946-4501 ext 3833 elizabeth.shah@uhn.ca

Locations
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Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Celeste Yu    416-946-4501 ext 5281    celeste.yu@uhn.ca   
Contact: Elizabeth Shah    416-946-4501 ext 3833    elizabeth.shah@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: David Cescon, MD Princess Margaret Cancer Centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03740503    
Other Study ID Numbers: GENIUS
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: December 6, 2023
Last Verified: December 2023

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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:
Cancer
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
Melanoma
Gastrointestinal Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Intestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Neoplasms
Female Urogenital Diseases