Ontario-wide Cancer TArgeted Nucleic Acid Evaluation

NCT02906943 | Recruiting

• 1 other identifier: OCTANE
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 7

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; Genitourinary Cancer; Pancreatobiliary Cancer; Gastrointestinal Cancer; Head and Neck Cancer; Rare Cancer; Unknown Primary Cancer

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Number of patients included in a province-wide registry of NGS panel-based testing results

  5 years

• Change in use of NGS panel-based testing in Ontario clinical genetic testing laboratories

  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

  5 years

• Change in rates of genomics based clinical research in Ontario

  5 years

• Utilization rates of province-wide genomically-characterized and clinically-annotated patient base in enrollment into specific research initiatives

  5 years

• Utilization rates of molecular profiling information provided to treating physicians in guiding future treatment decisions

  5 years

Secondary Outcomes (2)

• Percentage of successful linkages between transferred study data and administrative databases

  5 years

• Concordance between administrative data and clinically abstracted data comparing variables using 2x2 concordance tables

  5 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Advanced solid tumor malignancies, where archived formalin-fixed paraffin embedded (FFPE) is available and adequate for molecular profiling.

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (7)

Juravinski Cancer Centre

Hamilton, Ontario, Canada

ACTIVE NOT RECRUITING

Kingston General Hospital

Kingston, Ontario, Canada

ACTIVE NOT RECRUITING

London Health Sciences Centre

London, Ontario, Canada

ACTIVE NOT RECRUITING

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

RECRUITING

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, Canada

ACTIVE NOT RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

ACTIVE NOT RECRUITING

Related Publications (2)

• Kappel 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 DERIVED

• Ma 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 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Archival tumor tissue 2 tubes of whole blood

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Colorectal Neoplasms; Melanoma; Urogenital Neoplasms; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Neoplasms, Unknown Primary

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Bedard, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

• Lillian Siu, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samanta Del Rossi

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 20, 2016
• Study Start: August 1, 2016
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

CA (7)