Clinical trial · Observational
Ontario-wide Cancer TArgeted Nucleic Acid Evaluation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Genitourinary Cancer | Malignant Genitourinary System Neoplasm | ALIAS | 0.90 |
| Gynecological Cancer | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Advanced cancer
- description
- 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 outcomes (6)
- measure
- Number of patients included in a province-wide registry of NGS panel-based testing results
- timeFrame
- 5 years
- measure
- Change in use of NGS panel-based testing in Ontario clinical genetic testing laboratories
- timeFrame
- 5 years
- measure
- Number of patients included in province-wide repository of genomically-characterized tumour tissue and blood samples and their utilization rates for future research
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDBogdan L, Saleh RR, Avery L, Del Rossi S, Yu C, Bedard PL. Clinical Utility of Tumor Next-Generation Sequencing Panel Testing to Inform Treatment Decisions for Patients With Advanced Solid Tumors in a Tertiary Care Center. JCO Precis Oncol. 2024 Jun;8:e2400092. doi: 10.1200/PO.24.00092. PMID 38935894
- DERIVEDKappel C, Jiang DM, Wong B, Zhang T, Selvarajah S, Warner E, Hansen AR, Fallah-Rad N, Sacher AG, Stockley TL, Bedard PL, Sridhar SS. Comprehensive genomic profiling of treatment resistant metastatic castrate sensitive prostate cancer reveals high frequency of potential therapeutic targets. Clin Genitourin Cancer. 2022 Jun;20(3):278-284. doi: 10.1016/j.clgc.2022.02.004. Epub 2022 Feb 22. PMID 35337750
- DERIVEDMa LX, Espin-Garcia O, Bedard PL, Stockley T, Prince R, Mete O, Krzyzanowska MK. Clinical Application of Next-Generation Sequencing in Advanced Thyroid Cancers. Thyroid. 2022 Jun;32(6):657-666. doi: 10.1089/thy.2021.0542. Epub 2022 May 16. PMID 35262412