NCT02906943 Ontario-wide Cancer TArgeted Nucleic Acid Evaluation
| NCT ID | NCT02906943 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2016-08 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2016-08 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Patients with histological confirmation of advanced solid tumor malignancies who are candidates for systemic therapy. 2. All patients must have sufficient FFPE archived tumor tissue for molecular profiling. 3. Patient must be ≥ 18 years old. 4. Patient's ECOG performance status equal to 0 or 1. 5. All patients must have a life expectancy of \> 6 months. 6. All patients must have adequate organ functions. 7. All patients must have signed and dated an informed consent form. Exclusion Criteria: 1\. 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.
Contact & Investigator
Philippe Bedard, MD
PRINCIPAL INVESTIGATOR
Princess Margaret Hospital, Canada
Frequently Asked Questions
Who can join the NCT02906943 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02906943 currently recruiting?
Yes, NCT02906943 is actively recruiting participants. Contact the research team at samanta.delrossi@uhn.ca for enrollment information.
Where is the NCT02906943 trial being conducted?
This trial is being conducted at Hamilton, Canada, Kingston, Canada, London, Canada, Ottawa, Canada and 3 additional locations.
Who is sponsoring the NCT02906943 clinical trial?
NCT02906943 is sponsored by University Health Network, Toronto. The principal investigator is Philippe Bedard, MD at Princess Margaret Hospital, Canada. The trial plans to enroll 10,000 participants.
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