Genomic Investigation of Unusual Responders

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03740503
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Health Network, Toronto
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	David Cescon, MD
Principal Investigator Affiliation	Princess Margaret Cancer Centre
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9

Site Contact

Celeste Yu

[email protected]

416-946-4501 #5281

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