Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples

University Health Network, Toronto45 enrolled

Overview

This is a feasibility study to look for genetic alterations in tissue and blood samples that may be useful in determining what treatments may be useful in the patient's cancer care.

As part of the study, patients will have archival tumor tissue collected, and have tumor biopsies and blood samples taken. The samples will be tested for genetic alterations, and the results will be discussed with the patient including potential treatments. If patients agree, after they have received treatment for their cancer and their disease progresses, a second biopsy procedure will be done.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Colorectal Cancer Breast Cancer Gynecological Cancer Metastatic Eligible for Phase I or Phase II Study Melanoma Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years. * Histological or cytological proof of either metastatic breast, colorectal, gynecological or melanoma malignancy. * At least one biopsiable lesion deemed medically accessible and safe to biopsy. * Candidate for one or more phase I or II clinical trials at the time of study enrollment or at a later time point. * Fulfills local institution's laboratory parameters for tumor biopsy. * Willingness and ability of patient to provide signed voluntary informed consent. Exclusion Criteria: * Any condition that could interfere with a patient's ability to provide informed consent such as dementia or severe cognitive impairment. * Any contraindication to undergoing a biopsy procedure.

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached.

Time frame: 2 years

Secondary Outcomes

The rate of acceptable tumor samples from fresh core needle biopsy samples/total number of fresh core needle biopsy samples greater than or equal to 90%

Time frame: 2 years

The rate of acceptable tumor samples from fresh fine needle biopsy samples/total number of fresh fine needle biopsy samples greater than or equal to 50%

Time frame: 2 years

Successful analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 50%

Sequenom or MiSeq/TSCAP and MiSeq/NGS

Time frame: 2 years

Analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples from time from patient recruitment to final results, less than a defined period of time, in greater than or equal to 90%

Sequenom or MiSeq/TSCAP analysis from fresh core needle biopsy samples less than 4 weeks; sequenom or MiSeq/TSCAP analysis from fresh fine needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh core needle biopsy samples less than 8 weeks; MiSeq/NGS analysis from fresh fine needle biopsy samples less than 8 weeks

Time frame: 2 years

Actionable genomic result analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 30%

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.