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Genomic Investigation of Unusual Responders (GENIUS)

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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

Tracking Information
First Submitted Date October 23, 2018
First Posted Date November 14, 2018
Last Update Posted Date December 6, 2023
Actual Study Start Date November 1, 2013
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2018)		 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genomic Investigation of Unusual Responders
Official Title Genomic Investigation of Unusual Responders
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Archival tumor tissue, whole blood at baseline for germ-line DNA analysis
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.
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
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Madariaga A, Garg S, Bruce JP, Thiryayi S, Mandilaras V, Rath P, Oza AM, Dhani NC, Cescon DW, Lee YC, Chen E, Wang L, Clarke B, Lheureux S. Biomarkers of outcome to weekly paclitaxel in epithelial ovarian cancer. Gynecol Oncol. 2020 Nov;159(2):539-545. doi: 10.1016/j.ygyno.2020.08.032. Epub 2020 Sep 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 12, 2018)		 100
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2024
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Celeste Yu 416-946-4501 ext 5281 celeste.yu@uhn.ca
Contact: Elizabeth Shah 416-946-4501 ext 3833 elizabeth.shah@uhn.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03740503
Other Study ID Numbers GENIUS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party University Health Network, Toronto
Original Responsible Party Same as current
Current Study Sponsor University Health Network, Toronto
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: David Cescon, MD Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date December 2023