NCT01802905

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2013

Enrollment Period

2.7 years

First QC Date

February 27, 2013

Last Update Submit

February 4, 2015

Conditions

Advanced Incurable Cancers

Keywords

neoplasmmetastatic cancercancer genomegenomic analysisadults

Outcome Measures

Primary Outcomes (1)

  • Frequency of actioanble genomic abnormalites detected that modify treatment

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

    up to 24 months

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

    up to 24 months

Study Arms (1)

Sequenced patients

EXPERIMENTAL

Patients enrolled on the study who have successful sequencing of their cancers will be closely monitored for: what chemotherapy agents are next used, what response and toxicity do they have, is there any early sign of response detected on PET-CT, overall did the genomic information change treatment decision-making.

Genetic: in depth genomic sequencing

Interventions

in depth genomic sequencingGENETIC

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.

Sequenced patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Cancer Agency

Vancouver, British Columbia, Canada

Location

Related Publications (1)

  • Peixoto RD; Li Y; Pleasance E; Yip S; et al. A case of the utilization of genomic information in the management of metastatic colorectal cancer. J Clin Oncol 30: 2012 (suppl 34; abstr 444)

    BACKGROUND

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Janessa J. Laskin, MD FRCPC

    British Columbia Cancer Agency

    PRINCIPAL INVESTIGATOR

  • Marco Marra, PhD FRSC

    Genome Sciences Centre, BC Cancer Agency

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2013

First Posted

March 4, 2013

Study Start

June 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 5, 2015

Record last verified: 2013-02

Locations

CA(1)