Skip to main content
OpenTrials
Completed

NCT Number: NCT01802905

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

Most systemic therapies are chosen on the basis of large randomized clinical trials; however, tumour heterogeneity means that cancers with similar histological features may have substantially different underlying biological drivers. The investigators propose that applying personal genomic information prospectively obtained in a clinically realistic timeframe to assist in chemotherapy decision-making could result in more effective and efficient cancer treatment. This study will investigate this approach in a cross section of advanced cancers to examine timeliness, deliverability, rate of actionable targets identified, and our ability to expand this approach into a larger clinical trial setting.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Cancer Agency

Vancouver, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must have histologically or cytologically confirmed diagnosis of cancer
  • This cancer must be incurable, as defined by their treating oncologist (generally because of advanced stage).
  • 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.
  • ECOG PS 0 or 1.
  • Age > 18 years of age.
  • Subject consent must be obtained according to the BCCA requirements.
  • Subject must be accessible for treatment and follow-up. Subjects must be registered at the BCCA Vancouver site.

Exclusion criteria

  • Unable or unwilling to undergo tumour biopsy(s) and/or blood/skin samples for normal DNA.
  • Significant medical condition that in the opinion of the treating oncologist renders the subject not suitable for participation.

Treatment and study plan

in depth genomic sequencing

Genetic

Fresh tumour biopsies and matched normal specimens (blood and surrounding tissue) and when possible archival pretreatment specimens, will undergo in depth DNA and RNA sequencing and analysis on an oncogene panel.

Primary outcomes

  1. Frequency of actioanble genomic abnormalites detected that modify treatment

    Time frame: up to 24 months

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

Secondary outcomes

  1. What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test

    Time frame: up to 24 months

    What is the frequency with which these actionable results actually result in a subject receiving a drug(s) related to this test.

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Collaborators

  • BC Cancer Foundation

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2013
Registry last updated
Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.