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NCT Number: NCT03740503

Genomic Investigation of Unusual Responders

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.

Recruiting

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Key information

Conditions

Cancer Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma of Unknown Primary Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genitourinary Cancer Gynecological Cancer Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Melanoma (Skin) Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplasms, Unknown Primary Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-small Cell Lung Cancer Pancreatobiliary Gastrointestinal Cancer Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Cancer Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Upper Aerodigestive Tract Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient must have either an exceptionally good or poor response to treatment, as indicated by their treating physician.
  • 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
  • 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)
  • The patient must have sufficient archival tumor available for sequencing.
  • 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

Treatment and study plan

Primary outcomes

  1. Genomic Characterization of Tumor Samples

    Time frame: Through study completion, up to 2 years

    Characterization of the genetic changes that may explain a tumor's exceptional response or disaster to therapeutc agents.

Study contacts

Contact information is provided by the study sponsor or research team.

Celeste Yu

CONTACT

[email protected]

416-946-4501 ext. 5281

Elizabeth Shah

CONTACT

[email protected]

416-946-4501 ext. 3833

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Acronym: GENIUS

Important dates

Study start
2013
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2018
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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