Genomic Investigation of Unusual Responders
Recruiting · NCT03740503 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Health Network, Toronto
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- The patient must have either an exceptionally good or poor response to treatment, as indicated by their treating physician.
- 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
- 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)
- The patient must have sufficient archival tumor available for sequencing.
- 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
Where it is running
1 location listed.
- Princess Margaret Cancer Centre - Toronto, Ontario, Canada