Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples

A Feasibility Study of Genomic Profiling Methods and Timing of Sample Collection to Evaluate Clonal Evolution and Tumor Heterogeneity

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Colorectal Cancer; Metastatic; Gynecological Cancer; Melanoma Cancer; Eligible for Phase I or Phase II Study

Detailed Description

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 (Actual): 45

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

metastatic breast, colorectal, gynecological cancer or melanoma

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
metastatic colorectal cancer
metastatic breast cancer
metastatic gynecological cancer
metastatic melanoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient recruitment for paired core and fine needle biopsy greater than or equal to 50% of those screened or approached.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%		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%		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	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	2 years
Actionable genomic result analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 30%		2 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Princess Margaret Hospital, Canada; Ontario Institute for Cancer Research
• Investigators: Principal Investigator: Bedard Philippe, MD, Princess Margaret Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2012
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: October 5, 2012
• First Submitted That Met QC Criteria: October 5, 2012
• First Posted (Estimate): October 10, 2012

Study Record Updates

• Last Update Posted (Actual): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: DNA; sequencing; genome; tissue; tumor; biopsy; gene; expression; genomic analysis; archival; core needle; fine needle
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neuroendocrine Tumors; Nevi and Melanomas; Colorectal Neoplasms; Melanoma
• Other Study ID Numbers: MATCH-001