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Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies


N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Incurable Cancers

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Trial Information

Utilization of Genomic Information to Augment Chemotherapy Decision-making for People With Incurable Malignancies


It is clear that carcinogenesis is an immensely complex process and that even within a
histologic cancer subtype - such as adenocarcinoma of the lung or breast - there is
significant heterogeneity in cancer behaviour and response to therapy. Recognizing genetic
mutations that promote disease facilitates targeted treatment; this has been demonstrated in
several small subgroups of cancers in which specific genetic mutations or translocations
have been successfully treated with targeted chemotherapy agents.

Analyses of individual patients demonstrate unique molecular signatures for every cancer
examined. Frequently, multiple different pathways are involved in disease growth and
progression and the dominant process varies from person to person and perhaps even within
different sites of disease within one person. As well these variations evolve in response to
treatment. With many recognized mutations personalized evaluation of the genetic signature
encoded in DNA and RNA may enable directed therapy to the appropriate oncologic pathway
thereby providing information to help guide chemotherapy choices.


Inclusion Criteria:



1. Subjects must have histologically or cytologically confirmed diagnosis of cancer

2. This cancer must be incurable, as defined by their treating oncologist (generally
because of advanced stage).

3. Subjects must agree to provide archival tissue and agree to undergo a study specific
biopsy and blood test for genetic analysis. All subjects would have a biopsy and
blood samples at progression if it could be done safely.

4. ECOG PS 0 or 1.

5. Age > 18 years of age.

6. Subject consent must be obtained according to the BCCA requirements.

7. Subject must be accessible for treatment and follow-up. Subjects must be registered
at the BCCA Vancouver site.

Exclusion Criteria:

1. Unable or unwilling to undergo tumour biopsy(s) and/or blood/skin samples for normal
DNA.

2. Significant medical condition that in the opinion of the treating oncologist renders
the subject not suitable for participation.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Frequency of actioanble genomic abnormalites detected that modify treatment

Outcome Description:

What is the frequency of "actionable" results in this varied tumour population ?

Outcome Time Frame:

up to 24 months

Safety Issue:

No

Principal Investigator

Janessa J. Laskin, MD FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

Canada: Ethics Review Committee

Study ID:

BCCA POG 01

NCT ID:

NCT01802905

Start Date:

June 2012

Completion Date:

June 2014

Related Keywords:

  • Advanced Incurable Cancers
  • neoplasm
  • metastatic cancer
  • cancer genome
  • genomic analysis
  • adults

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