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Cancer DNA Screening Pilot Study (CANDACE) (CANDACE)

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ClinicalTrials.gov Identifier: NCT02808884
Recruitment Status : Active, not recruiting
First Posted : June 22, 2016
Last Update Posted : July 11, 2018
Sponsor:
Collaborators:
University of British Columbia
University of Utah
Pathway Genomics
Boreal Genomics
Information provided by (Responsible Party):
British Columbia Cancer Agency

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

Condition or disease Intervention/treatment Phase
Circulating Tumor Cells Genetic: Circulating tumor DNA assay Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
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
Official Title: Cancer DNA Screening Pilot Study (CANDACE)
Study Start Date : September 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Circulating tumor DNA assay- First test - Negative result
Once the data is analyzed, participants with a negative result will be sent an email thanking them for their participation and informing them of the negative result.
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.

Experimental: Circulating tumor DNA assay - Second test- Negative result
Participants whose sample provided a positive result after first test, will be contacted immediately by telephone by an oncologist co-investigator and concurrently sent a letter by mail informing them of the result and asking them to return for a second blood draw. We expect that this communication will happen with about a month of the original blood draw. The letter will include contact information for the study team and the oncologist co-investigators, in case the participant has any questions or concerns at this stage. A requisition form will be sent with the letter. Two 10mL tubes of blood will be drawn at the blood collection visit, to allow repeat testing and confirmation that the mutation is present consistently. Once the data is analyzed, participants with a negative result will be sent an email thanking them for their participation and informing them of the negative result.
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.

Experimental: Circulating tumor DNA assay - Second test- Positive result
Participants with positive results after first test will be contacted by an oncologist and sent a letter informing them of the result. They will be ask to return for a second blood draw. The letter will include contact info of the study team and the oncologist co-investigators. A requisition form will be sent with the letter. Two 10mL tubes of blood will be drawn to allow repeat testing and confirmation that the mutation is consistently present. Participants whom additional blood sample yields a positive result for the same cancer mutations seen in the first blood draw, will be contacted by an oncologist to explain the results and next steps. This should happen within about a week of the second blood draw. Pending oncological evaluation of the participant and study results, a PET-CT scan with FDG agent, and possibly other tests will be requested. Unless exams suggest otherwise, the default follow-up will be a full body PET-CT.
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.




Primary Outcome Measures :
  1. 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:

    • Number of False Positive Tests - The number of participants with a confirmed positive blood test who participated in a diagnostic evaluation during which no cancer was found.
    • Number of True Positive Tests - The number of participants with a confirmed blood test who participated in a diagnostic evaluation during which a cancer was found.


Secondary Outcome Measures :
  1. The enrollment rates for this study [ Time Frame: 1-2 years ]
    Based on the recruitment data from the participants of the BC Generations Project, the participant enrollment rates will be determine quarterly, semi-annually and yearly.

  2. The number of repeated versus sporadic positive test results within a year of the last blood draw. [ Time Frame: 1-2 years ]
    After the last blood draw, data will be analyzed to determine the number of repeated versus sporadic positive test results (i.e. how often does the test provide the same results on separate blood draws from the same individual, versus different results).

  3. The rate of participation in the medical imaging component of the study once a positive test result has been confirmed. [ Time Frame: 1-2 years ]
    After the last blood draw, data will be analyzed to determine the rate of participation in the medical imaging component of the study once a positive test result has been confirmed within a year.

  4. The number of medical imaging scans required per thousand individuals enrolled in the study. [ Time Frame: 1-2 years ]
    After the last blood draw, data will be analyzed to determine how often medical imaging scans were required per thousand of enrolled participants.

  5. The number of participants with abnormal medical imaging scans and of those cohorts, what fraction is cancer found. [ Time Frame: 1-2 years ]

    After the last blood draw, data will be analyzed to determine:

    Of the participants with abnormal medical imaging scans

    • what fraction is conclusively diagnosed with cancer within 2 months.
    • The number of curable cancers found
    • The number of incurable metastatic cancers found
    • The number of participants in whom cancer is found by one year after the blood sample, by any means.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have never been diagnosed with cancer (except for non-melanoma skin cancer)
  • Must be able to read and understand a consent form in English
  • Be willing to consent to the required blood draws, medical exam and PET-CT scans
  • Be willing to consent to any medical data related to this test, the imaging scans, and related follow up, being shared with the study investigators for the following year
  • Be in good health and able to donate three tubes of blood
  • Must have email
  • Must be able to have blood work in the greater Vancouver area

Exclusion Criteria:

  • Immunocompromised individuals
  • Contra-indications to MRI or PET-CT
  • Individuals with bleeding disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808884


Locations
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Canada, British Columbia
BC Cancer Agency- Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
British Columbia Cancer Agency
University of British Columbia
University of Utah
Pathway Genomics
Boreal Genomics
Investigators
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Principal Investigator: Alan Nichol British Columbia Cancer Agency

Publications:
Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.

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Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT02808884     History of Changes
Other Study ID Numbers: H16-00519
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only participants have the option of receiving their own personal data.
Additional relevant MeSH terms:
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Neoplastic Cells, Circulating
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes