Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT04151342

Conditions

Cancer

Malignancies Multiple

Malignant Solid Tumor

Cancer, Therapy-Related

Molecular Sequence Variation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents.

Patient-reported outcomes (PROs)

Study Details

Brief summary:

This study will collect data on Canadian cancer patients that have uncommon/rare changes in their tumours, such as alterations/rearrangements in the genetic material inside cells - known as deoxyribonucleic acid, or DNA, which acts as a map and gives directions to the cells on how to make other substances the body needs - because some of these changes have been found to respond to different drugs that help to stop the cancer. These rare changes occur in genes such as but not limited to ALK, EGFR, ROS1, BRAF, and NTRK which have targeted drugs in a family known as tyrosine kinase inhibitors (TKIs), and KRAS G12C mutation, which now has a targeted inhibitor drug therapy for patients with non small cell lung cancer (NSCLC). The goals for the study are to compare the natural history of such cancers and the treatment outcomes, including toxicities and patient-reported outcomes, for the different therapies.

Conditions

Cancer

Malignancies Multiple

Malignant Solid Tumor

Cancer, Therapy-Related

Molecular Sequence Variation

Study ID

NCT04151342

Start date

Jan 17, 2020

Status verified date

Nov, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients ≥ 18 years at cancer diagnosis
  • Diagnosed with malignant tumour(s) with molecular testing completed that identified rare molecular alterations
  • Accessible/available molecular testing reports/documentation to confirm type(s) of molecular alteration(s) (resulting from the conduct of polymerase chain reaction \[PCR\] based next generation sequencing \[NGS\], immunohistochemistry \[IHC\], fluorescence in situ hybridization \[FISH\], liquid biopsy)
  • Canadian resident received follow-up for cancer care in Canada or is currently receiving/planning follow-up for cancer care to occur in Canada at time of enrollment

Exclusion Criteria:

  • Previous refusal of the deceased patient, when living, to enroll in this study or patient approached for this study is unable to provide informed consent

Study Design

Enrollment

5500 participants

Anticipated

Interventions and Outcome Measures

Arms

Prospective

Living cancer patients with histologically confirmed rare molecular alterations in their tumours, such as in ALK, EGFR, ROS1, BRAF, and KRAS G12C from participating sites/cancer centres across Canada.

Retrospective

Deceased cancer patients who had histologically confirmed rare molecular alterations in their tumours, such as in ALK, EGFR, ROS1, BRAF, and KRAS G12C from participating sites/cancer centres across Canada.

Comparator group

All cancer patients without rare molecular alterations in their solid tumours. This group will be established in order to determine baseline characteristics and outcomes, including treatment outcomes, of more standard treatments such as systemic chemotherapy or immunotherapy.

Interventions

Cancer treatment with tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapeutic agents.

Observing cancer patients who have received or are currently receiving tyrosine kinase inhibitors (TKIs) or other molecularly targeted therapies for their cancer treatment.

Patient-reported outcomes (PROs)

Prospectively enrolled participants will be provided with survey packets comprised of different PRO instruments at the initial/baseline visit, at 3 month follow up intervals and at the time when treatment/therapy is changed.

Primary outcome measure

  • Composite of Progression Free Survival [PFS] or Overall Survival [OS] [ Time Frame: From the start date of cancer therapy until the date of first documented progression or date of death (any cause), assessed up to 120 months ]

Central Contacts and Locations

Central contacts

Faisal Al-Agha, BSc

416-946-4501faisal.al-agha@uhn.ca

Roula Raptis, MSc

416-864-6060Roula.Raptis@unityhealth.to

Locations

Tom Baker Cancer Centre - University of Calgary - Alberta Health Services

Recruiting

Calgary, Alberta, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Vishal Navani, MA (Oxon), MBBS, MRCP, FRACP

BC Cancer

Recruiting

Vancouver, British Columbia, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Cheryl Ho, MD, FRCPC

CancerCare Manitoba/University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Shantanu Banerji, MD, FRCPC

Dr. Everett Chalmers Regional Hospital

Recruiting

Fredericton, New Brunswick, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Luisa Galvis-Gomez, MD

Queen Elizabeth II (QEII) Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Stephanie Snow, MD, FRCPC

William Osler Health System - Brampton Civic Hospital

Recruiting

Brampton, Ontario, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Parneet Cheema, MD, FRCPC

Health Sciences North

Recruiting

Greater Sudbury, Ontario, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Abhenil Mittal, MD

Hamilton Health Sciences - Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Rosalyn Juergens, MD, PhD

Kingston Health Sciences Centre (KHSC)

Recruiting

Kingston, Ontario, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Sofia Genta, MD

Lawson Health Research Institute - London Health Sciences Centre

Recruiting

London, Ontario, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Sara Kuruvilla, MD, FRCPC

Ottawa Hospital Cancer Centre

Recruiting

Ottawa, Ontario, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Paul Wheatley-Price, MBChB, FRCP(UK), MD

Princess Margaret Cancer Centre (PMCC) - University Health Network (UHN)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Faisal Al-Agha, BSc

416-946-4501faisal.al-agha@uhn.ca

Principal Investigator:

Geoffrey Liu, MD, MSc

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Ronald Burkes, MD, FRCPC

Sunnybrook Research Institute - Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Ines Menjak, MD, FRCPC

Centre hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Normand Blais, MD, MSc

Hôpital du Sacré-Coeur-de-Montréal (HSCM)

Recruiting

Montreal, Quebec, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Kevin Jao, MD, PhD

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Jason Agulnik, MD

Centre hospitalier universitaire de Sherbrooke (CHUS)

Recruiting

Sherbrooke, Quebec, Canada

Contacts

Roula Raptis, MSc

Roula.Raptis@unityhealth.to

Principal Investigator:

Nicole Bouchard, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 3, 2025

Last verified

Nov, 2025

Keywords

  • observational study
  • cancer
  • cancer therapies
  • molecular alterations
  • real-world evidence
  • real-world data
  • tyrosine kinase inhibitors
  • ambispective
  • ras GTPase inhibitors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-12-03.