Genomic Investigation of Unusual Responders

Recruiting

• Conditions: Breast Cancer; Genitourinary Cancer; Upper Aerodigestive Tract Cancer; Pancreatobiliary Gastrointestinal Cancer; Colorectal Cancer; Cancer; Non-small Cell Lung Cancer; Rare Cancer; Carcinoma of Unknown Primary; Gynecological Cancer

• Registration Number: NCT03740503
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-01
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-11-12
• Study First Posted: 2018-11-14
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genomic Characterization of Tumor Samples	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.

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada