Skip to content

Genomic Investigation of Unusual Responders

Genomic Investigation of Unusual Responders

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03740503
Acronym
GENIUS
Enrollment
100
Registered
2018-11-14
Start date
2013-11-01
Completion date
2025-11-30
Last updated
2025-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Cancer, Carcinoma of Unknown Primary, Colorectal Cancer, Genitourinary Cancer, Gynecological Cancer, Melanoma (Skin), Non-small Cell Lung Cancer, Pancreatobiliary Gastrointestinal Cancer, Rare Cancer, Upper Aerodigestive Tract Cancer

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

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.

Interventions

None listed

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Genomic Characterization of Tumor SamplesThrough study completion, up to 2 yearsCharacterization of the genetic changes that may explain a tumor's exceptional response or disaster to therapeutc agents.

Countries

Canada

Contacts

Primary ContactCeleste Yu
celeste.yu@uhn.ca416-946-4501
Backup ContactElizabeth Shah
elizabeth.shah@uhn.ca416-946-4501

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026