Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT01703585

Collaborator

Ontario Institute for Cancer Research (Other), Princess Margaret Hospital, Canada (Other)

Enrollment

Location

66.9

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Breast Cancer Gynecological Cancer Metastatic Eligible for Phase I or Phase II Study Melanoma Cancer

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 Design

Study Type:

Observational

Actual Enrollment :

45 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 4, 2012

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
metastatic breast cancer
metastatic colorectal cancer
metastatic gynecological cancer
metastatic melanoma

Outcome Measures

Primary Outcome Measures

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

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% [2 years]
Sequenom or MiSeq/TSCAP and MiSeq/NGS
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% [2 years]
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
Actionable genomic result analysis of fresh core needle biopsy samples and fresh fine needle biopsy samples greater than or equal to 30% [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.