Feasibility Study of Genomic Profiling Methods and Timing in Tumor Samples

NCT ID: NCT01703585

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-04

Study Completion Date

2018-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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metastatic breast cancer

No interventions assigned to this group

metastatic colorectal cancer

No interventions assigned to this group

metastatic gynecological cancer

No interventions assigned to this group

metastatic melanoma

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ontario Institute for Cancer Research

OTHER

Sponsor Role collaborator

Princess Margaret Hospital, Canada

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lillian Siu, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Bedard Philippe, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Locations

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Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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MATCH-001

Identifier Type: -

Identifier Source: org_study_id

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