Cancer DNA Screening Pilot Study (CANDACE)

Summary

The investigators have developed an assay that can sensitively and specifically detect DNA mutations circulating in human plasma that may be indicators of the presence of a solid tumor. This study is a pilot study to measure positive and negative predictive values of this assay as an indicator of the presence of a tumor in normal subjects

Conditions

• Circulating Tumor Cells

Interventions

GENETIC

Circulating tumor DNA assay

Blood samples will be separated into plasma and cellular fraction including erythrocytes and buffy coat.The plasma fraction will be placed in a separate tube and frozen for subsequent analysis. Frozen plasma samples, de-identified, will be delivered to Pathway Genomics where DNA content will be analyzed with a circulating tumor DNA assay employing the UBC/Boreal Genomics enrichment technology. All of the participants' plasma will be sent to Pathway, where it will be used up in the assay. Circulating tumor DNA assay results (raw sequencing data) from Pathway Genomics will be returned to UBC and analyzed for the presence of cancer mutations. Any samples showing activating mutations above the assay's technical Limit of Detection (LOD) will be called positive. One exception will be made for TP53 mutations that are known to exist in some normal individuals at low levels. For these mutations, a level of 0.1% will be set, above which the sample will be called positive.

Sponsors & Collaborators

• University of British Columbia

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Pathway Genomics

  collaborator INDUSTRY

• Boreal Genomics

  collaborator UNKNOWN

• British Columbia Cancer Agency

  lead OTHER

Principal Investigators

• Alan M Nichol, MD · British Columbia Cancer Agency

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

55 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-09-19

Primary Completion

2019-06-10

Completion

2019-06-10

Countries

• Canada

Study Locations