Genomic Investigation of Unusual Responders

Genomic Investigation of Unusual Responders

Sponsors

Lead Sponsor: University Health Network, Toronto

Source 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.

Overall Status Recruiting
Start Date 2013-11-01
Completion Date 2022-11-01
Primary Completion Date 2022-11-01
Study Type Observational
Primary Outcome
Measure Time Frame
Genomic Characterization of Tumor Samples Through study completion, up to 2 years
Enrollment 100
Condition
Eligibility

Sampling Method:

Non-Probability Sample

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
David Cescon, MD Principal Investigator Princess Margaret Cancer Centre
Overall Contact

Last Name: Celeste Yu

Phone: 416-946-4501

Phone Ext.: 5281

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Princess Margaret Cancer Centre Celeste Yu 416-946-4501 5281 [email protected]
Location Countries

Canada

Verification Date

2020-12-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Acronym GENIUS
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

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