RecruitingNCT02906943

Ontario-wide Cancer TArgeted Nucleic Acid Evaluation


Sponsor

University Health Network, Toronto

Enrollment

10,000 participants

Start Date

Aug 1, 2016

Study Type

OBSERVATIONAL

Conditions

Summary

Substantial progress has been made in the treatment of cancer through the use of targeted therapies, but what works for one patient might not work for another patient. Certain drugs are now being developed that target specific molecules in the body that are believed to be part of the disease. Biomarkers are specific characteristics of the cancer that may help provide prognostic information (e.g. how well patients will be regardless of the treatments given) or help predict sensitivity or resistance to a specific treatment. The study will collect archival tumor samples (previously collected biopsy or surgical tumor samples) to provide biomarker data about a patient's cancer, which may help their physicians to identify which clinical trials of new drug treatments may be most appropriate for the patient in the future and may also guide the use of approved treatments that may potentially benefit the patient. Another goal of this study is to develop a province-wide registry of targeted gene sequencing testing results that will be made available to cancer researchers. Additional tumour tissue and blood samples collected from all study participants will also be stored in a biobank at the Ontario Institute for Cancer Research for future research. The study will also look at linking data from this study to other health care databases to further collect information about the health care the patients received, including medical tests, clinic visits, or procedures both before and after participating in this study. Having more information about patient health to relate to the DNA sequences may provide new insights into cancer and its treatment.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Patients with histological confirmation of advanced solid tumor malignancies who are candidates for systemic therapy.
  • All patients must have sufficient FFPE archived tumor tissue for molecular profiling.
  • Patient must be ≥ 18 years old.
  • Patient's ECOG performance status equal to 0 or 1.
  • All patients must have a life expectancy of \> 6 months.
  • All patients must have adequate organ functions.
  • All patients must have signed and dated an informed consent form.

Exclusion Criteria1

  • \. Patients must not have received more than 2 lines of prior cytotoxic therapy for their recurrent/metastatic disease, with the exception of Phase I trial candidates who will not be excluded if more than 2 lines of prior cytotoxic therapy have been received.

Locations(7)

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Kingston General Hospital

Kingston, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT02906943


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