Genomic Investigation of Unusual Responders

Breast Cancer Clinical Trial

— GENIUS  

Official title:

Genomic Investigation of Unusual Responders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03740503
• Other study ID #: GENIUS
• Status: Recruiting
• Start date: November 1, 2013
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: Celeste Yu
• Phone: 416-946-4501
• Email: celeste.yu[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genomic Characterization of Tumor Samples	Characterization of the genetic changes that may explain a tumor's exceptional response or disaster to therapeutc agents.	Through study completion, up to 2 years