Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT03740503

Conditions

Cancer

Breast Cancer

Non-small Cell Lung Cancer

Colorectal Cancer

Genitourinary Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Studies have shown that tumors from the same patient may respond very differently to the same therapeutic agents. This study aims to investigate the genetic basis of tumors that respond abnormally well or poorly to therapeutic agents in an effort to understand the fundamental genetic basis of this response. The present protocol seeks to retrospectively perform Exome, next-generation (DNA) sequencing and/or other molecular techniques on tumor samples to identify the genetic basis of a patient's exceptional response to chemotherapy.

Conditions

Cancer

Breast Cancer

Non-small Cell Lung Cancer

Colorectal Cancer

Genitourinary Cancer

Study ID

NCT03740503

Start date

Nov 1, 2013

Status verified date

Jan, 2025

Completion date

Nov, 2025

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. The patient must have either an exceptionally good or poor response to treatment, as indicated by their treating physician.

1. The exact definition of this is adaptable to the disease but a suggested guideline is a Complete Response, Partial Response or progression free interval of at least 6 months
2. Exceptionally poor response includes patients who were expected to respond favourably to a treatment but instead responded poorly (e.g dramatic tumor growth or death)
2. The patient must have sufficient archival tumor available for sequencing.
3. Deceased patients will also be considered for analysis (up to 30 patients per year) if they meet at least one of the following requirements:

a)) Patients who have archival tissue stored within the UHN Laboratory Medicine Program who have had a consent waiver granted by the REB to access the tissue.

b) Patients who have archival tissue banked for further research within the UHN Biospecimen Sciences Program

Exclusion Criteria:
  • None

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Genomic Characterization of Tumor Samples [ Time Frame: Through study completion, up to 2 years ]

Central Contacts and Locations

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jan 31, 2025

Last verified

Jan, 2025

Keywords

  • Cancer
  • Breast Cancer
  • Non- small Cell Lung Cancer
  • Colorectal Cancer
  • Genitourinary Cancer
  • Gynecological Cancer
  • Upper Aerodigestive Tract Cancer
  • Pancreatobiliary Gastrointestinal Cancer
  • Melanoma Cancer
  • Rare Cancer
  • Unknown Primary Cancer

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 2025-01-31.