Cancer DNA Screening Pilot Study (CANDACE) (CANDACE)
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ClinicalTrials.gov Identifier: NCT02808884 |
Recruitment Status :
Completed
First Posted : June 22, 2016
Last Update Posted : August 24, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | June 7, 2016 | ||||
First Posted Date ICMJE | June 22, 2016 | ||||
Last Update Posted Date | August 24, 2020 | ||||
Actual Study Start Date ICMJE | September 19, 2016 | ||||
Actual Primary Completion Date | June 10, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Measuring the positive and negative predictive value of a circulating tumor DNA blood test in detecting the presence of cancer or pre-cancerous lesions [ Time Frame: 1-2 years ] Within a year of all blood sample collections, the following will be determined:
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Cancer DNA Screening Pilot Study (CANDACE) | ||||
Official Title ICMJE | Cancer DNA Screening Pilot Study (CANDACE) | ||||
Brief 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 | ||||
Detailed Description | Participants consenting for the study will be requested to consent for an initial collection of two vials of blood (~ 20 ml total) and to answer questions regarding aspects of their medical history and lifestyle that are relevant to cancer risk. Participants in the study will also be asked to provide consent for follow-up blood samples, and if the confirmatory tests show a positive result, follow-up PET/CT scans and other investigations. 1,000 participants between the ages of 55 and 75 will be enrolled through BC Generations Project. This is a invite-only study.
Data collected in this study will be provided to BC Generations Project. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Intervention Model Description: Blood test screening for all who wish to participant. Additional screening test for those who test positive twice. Masking: None (Open Label)Primary Purpose: Screening |
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Condition ICMJE | Circulating Tumor Cells | ||||
Intervention ICMJE | 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.
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
1514 | ||||
Original Estimated Enrollment ICMJE |
1000 | ||||
Actual Study Completion Date ICMJE | June 10, 2019 | ||||
Actual Primary Completion Date | June 10, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 55 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02808884 | ||||
Other Study ID Numbers ICMJE | H16-00519 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | British Columbia Cancer Agency | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | British Columbia Cancer Agency | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | British Columbia Cancer Agency | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |