Recruiting

Cancer Nucleic Acids

Sponsor:

University Health Network, Toronto

Code:

NCT02906943

Conditions

Breast Cancer

Lung Cancer

Colorectal Cancer

Melanoma

Gynecological Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Breast Cancer

Lung Cancer

Colorectal Cancer

Melanoma

Gynecological Cancer

Study ID

NCT02906943

Start date

Aug, 2016

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Advanced cancer

Patients with advanced, incurable solid tumors receiving standard palliative treatment(s) will have archival tumor specimens requested and used for targeted next generation sequencing (NGS) testing. Blood samples and additional archival tumor specimens will be collected for banking and future research purposes.

Primary outcome measure

  • Number of patients included in a province-wide registry of NGS panel-based testing results [ Time Frame: 5 years ]
  • Change in use of NGS panel-based testing in Ontario clinical genetic testing laboratories [ Time Frame: 5 years ]
  • Number of patients included in province-wide repository of genomically-characterized tumour tissue and blood samples and their utilization rates for future research [ Time Frame: 5 years ]
  • Change in rates of genomics based clinical research in Ontario [ Time Frame: 5 years ]
  • Utilization rates of province-wide genomically-characterized and clinically-annotated patient base in enrollment into specific research initiatives [ Time Frame: 5 years ]
  • Utilization rates of molecular profiling information provided to treating physicians in guiding future treatment decisions [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Samanta Del Rossi

416-946-4501samanta.delrossi@uhn.ca

Locations

The Ottawa Hospital Cancer Centre

Recruiting

Ottawa, Ontario, Canada

Contacts

Han (Jenny) Zhang

613-737-7700hanzhang@ohri.ca

Kendra Christink

613-737-7700kchristink@toh.ca

Principal Investigator:

John Hilton, MD

Princess Margaret Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Samanta Del Rossi

416-946-4501samanta.delrossi@uhn.ca

Principal Investigator:

Philippe Bedard, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • Molecular Profiling
  • Advanced Cancer
  • Advanced Solid Tumors
  • Phase I Clinical Trial Candidates
  • Next Generation Sequencing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-05.