Genomic Investigation of Unusual Responders

NCT03740503 | Recruiting

• 1 other identifier: GENIUS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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; Gynecological Cancer; Upper Aerodigestive Tract Cancer; Pancreatobiliary Gastrointestinal Cancer; Melanoma (Skin); Rare Cancer; Carcinoma of Unknown Primary

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled who displayed exceptional response as well as those who were expected to respond favourably but displayed a poor outcome (e.g. drastic tumour growth or death) to their prescribed medication or treatment from a clinical trial.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Related Publications (1)

• Madariaga A, Garg S, Bruce JP, Thiryayi S, Mandilaras V, Rath P, Oza AM, Dhani NC, Cescon DW, Lee YC, Chen E, Wang L, Clarke B, Lheureux S. Biomarkers of outcome to weekly paclitaxel in epithelial ovarian cancer. Gynecol Oncol. 2020 Nov;159(2):539-545. doi: 10.1016/j.ygyno.2020.08.032. Epub 2020 Sep 8.

  PMID: 32912664 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Archival tumor tissue, whole blood at baseline for germ-line DNA analysis

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Urogenital Neoplasms; Melanoma; Neoplasms, Unknown Primary

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David Cescon, MD

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celeste Yu

CONTACT

416-946-4501; celeste.yu@uhn.ca

Elizabeth Shah

CONTACT

416-946-4501; elizabeth.shah@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 14, 2018
• Study Start: November 1, 2013
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

CA (1)