<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04495244</url>
  </required_header>
  <id_info>
    <org_study_id>241391</org_study_id>
    <nct_id>NCT04495244</nct_id>
  </id_info>
  <brief_title>A Study to Identify Breast Cancer (IDBC)</brief_title>
  <acronym>IDBC</acronym>
  <official_title>Investigation of a Novel Blood Test to Identify Breast Cancer (IDBC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Syantra Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Syantra Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Detecting cancer as early as possible is key to achieving positive outcomes in response to&#xD;
      diagnosis and treatment. The current project is aimed at validating a novel blood-based&#xD;
      breast cancer identification test (Syantra DX Breast Cancer) that has been developed by&#xD;
      Syantra Inc. Syantra DX Breast Cancer measures gene expression signatures in whole blood, and&#xD;
      has been retrospectively demonstrated in 780 samples. The test uses proprietary algorithms to&#xD;
      analyse gene expression characteristics from a novel multi-biomarker panel, and then classify&#xD;
      a sample as positive or negative for breast cancer. Based upon test performance in a&#xD;
      retrospective environment, a prospective validation study is being proposed.&#xD;
&#xD;
      The primary objective of this study is to validate Syantra DX Breast Cancer methodology and&#xD;
      biomarker panel using prospective samples, well categorized by diagnostic imaging scores,&#xD;
      pathology outcomes, and subject characteristics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current project is aimed at validating Syantra DX Breast Cancer in a UK population.&#xD;
      Results of the UK study will be combined with those from additional sites, including those in&#xD;
      Canada, with additional samples expected from the United States and South Korea. Syantra DX&#xD;
      Breast Cancer measures gene expression signatures in whole blood, and has been&#xD;
      retrospectively demonstrated in 780 samples. The test uses proprietary algorithms to analyse&#xD;
      gene expression characteristics from a novel multi-biomarker panel, and then classify a&#xD;
      sample as positive or negative for breast cancer. Based upon test performance in a&#xD;
      retrospective environment, a prospective validation study is being proposed, and is described&#xD;
      below.&#xD;
&#xD;
      The study seeks to evaluate performance of Syantra DX Breast Cancer in prospective samples&#xD;
      and to optimize test methodology and biomarkers. Key to performance of the study is&#xD;
      recruitment of women who have received an abnormal mammography report, and have been&#xD;
      classified under the UK Royal College of Radiologists Breast Group (RCRBG) scoring system in&#xD;
      categories 3 - 5. This will support the ability to employ the test for breast cancer&#xD;
      detection in a screening/call-back environment. To complete the study cohort, additional&#xD;
      women will be recruited from the population who have normal or benign mammography results&#xD;
      (RCRBG category 1 and 2), and/or a recent normal physical breast exam, with no history of&#xD;
      breast cancer. Blood samples will be acquired from all women following completion of an&#xD;
      informed consent procedure.&#xD;
&#xD;
      For those with an abnormal mammogram, blood will be drawn before a biopsy is performed. All&#xD;
      sample information will be de-identified, and the samples will be processed and analysed&#xD;
      according to Syantra DX Breast Cancer standard operating procedures. These procedures include&#xD;
      extracting sample RNA and aliquoting for storage in a manner that maintains sample anonymity.&#xD;
      All processing and analysis will be conducted in a blind environment without knowing the&#xD;
      associated RCRBG or pathology outcomes for any samples. Only after testing is complete will&#xD;
      sample classifications be revealed. Syantra DX Breast Cancer results will then be compared to&#xD;
      RCRBG, biopsy and pathology data to determine concordance, and statistics will be calculated.&#xD;
      If or when biomarker panel or test methodology is modified during the performance of the&#xD;
      study, samples will be reanalysed with updated test parameters. This reanalysis will make use&#xD;
      of a de-identified aliquot of sample RNA to ensure that testing is maintained in a blind&#xD;
      environment.&#xD;
&#xD;
      There is an optional part of the study procedure that is included as 'additional research'. A&#xD;
      specific question seeking approval for the additional research is included on the study&#xD;
      consent form. For individuals who agree to participate in the additional research, material&#xD;
      extracted from their blood sample will be stored for additional investigations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Performance of the Syantra DX Breast Cancer test as assessed by sensitivity and specificity</measure>
    <time_frame>through completion of the study, approximately eighteen months</time_frame>
    <description>The number of participants that test positive or negative for breast cancer with the Syantra DX Breast Cancer test and their breast cancer status as assessed by mammography or pathology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modulate test methodology to account for differences between retrospective and prospective samples</measure>
    <time_frame>through completion of the study, approximately eighteen months</time_frame>
    <description>Determine the sensitivity and specificity of the assay with biomarker panel modifications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance of the Syantra DX Breast Cancer test in prediction of molecular subtype of breast cancer as assessed by pathology</measure>
    <time_frame>through completion of the study, approximately eighteen months</time_frame>
    <description>Correlate the performance of the test to molecular characterizations of identified cancers as assessed by pathology of tissue from biopsy or resection.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>Investigational Population</arm_group_label>
    <description>Suspected Invasive Breast Cancer (any size) or DCIS (pre-invasive) are of particular interest. Women with abnormal screening mammograms (R3-5) recalled for further investigation.&#xD;
Inclusion criteria&#xD;
Women with suspected Invasive Breast Cancer (tumours of any size and/or DCIS).&#xD;
Individuals with an abnormal or suspicious screening mammogram recalled for further evaluation.&#xD;
Suspected Invasive Breast Cancer (tumours of any size and/or DCIS).&#xD;
Willing to give written Informed Consent and provide whole blood samples&#xD;
Age 30-75 years&#xD;
Exclusion criteria&#xD;
Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy)&#xD;
Inoperable (T4 category) or inflammatory breast cancer&#xD;
Previous history of cancer previously at any site&#xD;
Previous history of breast cancer&#xD;
Concomitant or other concurrent anti-cancer therapy&#xD;
Male&#xD;
No histopathological diagnosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Borderline (Atypica and LCIS) Population</arm_group_label>
    <description>Women with borderline pathological B3 lesions (suspected atypia Ductal or Lobular and benign proliferative disease without DCIS or invasion) Inclusion criteria&#xD;
Abnormal screening mammogram with suspected benign breast disease or proliferative changes&#xD;
Willing to give Written Informed Consent and provide whole blood samples&#xD;
Aged 30-75 years&#xD;
Exclusion criteria&#xD;
Existing cancer diagnosis&#xD;
Male&#xD;
Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy)&#xD;
Previous history of any cancer&#xD;
Previous history of breast cancer&#xD;
Concomitant or other concurrent anti-cancer therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Population</arm_group_label>
    <description>Healthy Controls Inclusion criteria&#xD;
Normal breast examination - No cancer detected/suspected by physical exam, diagnostic radiology or screening mammography&#xD;
Willing to give Written Informed Consent and provide whole blood samples&#xD;
Aged 30-75 years&#xD;
Exclusion criteria&#xD;
Cancer diagnosis&#xD;
Male&#xD;
Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy)&#xD;
Previous history of any cancer&#xD;
Concomitant or other concurrent anti-cancer therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Syantra DX Breast Cancer</intervention_name>
    <description>Blood test for detecting the presence of breast cancer.</description>
    <arm_group_label>Borderline (Atypica and LCIS) Population</arm_group_label>
    <arm_group_label>Control Population</arm_group_label>
    <arm_group_label>Investigational Population</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Populations will be selected from women visiting the Nightingale Centre at Wythenshaw&#xD;
        Hospital for breast cancer imaging.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Aged 30-75 years&#xD;
&#xD;
          -  Normal breast examination - No cancer detected/suspected by physical exam, diagnostic&#xD;
             radiology or screening mammography&#xD;
&#xD;
          -  Women with suspected Invasive Breast Cancer&#xD;
&#xD;
          -  Individuals with an abnormal or suspicious mammogram&#xD;
&#xD;
          -  Abnormal screening mammogram with suspected benign breast disease or proliferative&#xD;
             changes&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Cancer diagnosis&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Breast surgery within the previous 12 months (for any reason) or recent breast biopsy&#xD;
             (including needle core biopsy)&#xD;
&#xD;
          -  Previous history of any cancer&#xD;
&#xD;
          -  Concomitant or other concurrent anti-cancer therapy&#xD;
&#xD;
          -  Inoperable or inflammatory breast cancer&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self-identified</gender_description>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nigel Bundred, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Manchester University NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cliona Kirwin, MD</last_name>
    <role>Study Director</role>
    <affiliation>Manchester University NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hayley Brooks</last_name>
    <phone>0161 291 4045</phone>
    <email>Hayley.brooks@mft.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Linda Bailey</last_name>
    <phone>0161 291 4492</phone>
    <email>linda.bailey3@mft.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Wythenshawe Hospital, Southmoor Road</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hayley Brooks</last_name>
    </contact>
    <investigator>
      <last_name>Nigel Bundred, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Detection, blood test, clinical assay</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04495244
org study id: 241391
nct id: NCT04495244
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Detecting cancer as early as possible is key to achieving positive outcomes in response to
      diagnosis and treatment. The current project is aimed at validating a novel blood-based
      breast cancer identification test (Syantra DX Breast Cancer) that has been developed by
      Syantra Inc. Syantra DX Breast Cancer measures gene expression signatures in whole blood, and
      has been retrospectively demonstrated in 780 samples. The test uses proprietary algorithms to
      analyse gene expression characteristics from a novel multi-biomarker panel, and then classify
      a sample as positive or negative for breast cancer. Based upon test performance in a
      retrospective environment, a prospective validation study is being proposed.

      The primary objective of this study is to validate Syantra DX Breast Cancer methodology and
      biomarker panel using prospective samples, well categorized by diagnostic imaging scores,
      pathology outcomes, and subject characteristics.
The current project is aimed at validating Syantra DX Breast Cancer in a UK population.
      Results of the UK study will be combined with those from additional sites, including those in
      Canada, with additional samples expected from the United States and South Korea. Syantra DX
      Breast Cancer measures gene expression signatures in whole blood, and has been
      retrospectively demonstrated in 780 samples. The test uses proprietary algorithms to analyse
      gene expression characteristics from a novel multi-biomarker panel, and then classify a
      sample as positive or negative for breast cancer. Based upon test performance in a
      retrospective environment, a prospective validation study is being proposed, and is described
      below.

      The study seeks to evaluate performance of Syantra DX Breast Cancer in prospective samples
      and to optimize test methodology and biomarkers. Key to performance of the study is
      recruitment of women who have received an abnormal mammography report, and have been
      classified under the UK Royal College of Radiologists Breast Group (RCRBG) scoring system in
      categories 3 - 5. This will support the ability to employ the test for breast cancer
      detection in a screening/call-back environment. To complete the study cohort, additional
      women will be recruited from the population who have normal or benign mammography results
      (RCRBG category 1 and 2), and/or a recent normal physical breast exam, with no history of
      breast cancer. Blood samples will be acquired from all women following completion of an
      informed consent procedure.

      For those with an abnormal mammogram, blood will be drawn before a biopsy is performed. All
      sample information will be de-identified, and the samples will be processed and analysed
      according to Syantra DX Breast Cancer standard operating procedures. These procedures include
      extracting sample RNA and aliquoting for storage in a manner that maintains sample anonymity.
      All processing and analysis will be conducted in a blind environment without knowing the
      associated RCRBG or pathology outcomes for any samples. Only after testing is complete will
      sample classifications be revealed. Syantra DX Breast Cancer results will then be compared to
      RCRBG, biopsy and pathology data to determine concordance, and statistics will be calculated.
      If or when biomarker panel or test methodology is modified during the performance of the
      study, samples will be reanalysed with updated test parameters. This reanalysis will make use
      of a de-identified aliquot of sample RNA to ensure that testing is maintained in a blind
      environment.

      There is an optional part of the study procedure that is included as 'additional research'. A
      specific question seeking approval for the additional research is included on the study
      consent form. For individuals who agree to participate in the additional research, material
      extracted from their blood sample will be stored for additional investigations.
observational model: Cohort
time perspective: Prospective
measure: Performance of the Syantra DX Breast Cancer test as assessed by sensitivity and specificity
time frame: through completion of the study, approximately eighteen months
description: The number of participants that test positive or negative for breast cancer with the Syantra DX Breast Cancer test and their breast cancer status as assessed by mammography or pathology.
measure: Modulate test methodology to account for differences between retrospective and prospective samples
time frame: through completion of the study, approximately eighteen months
description: Determine the sensitivity and specificity of the assay with biomarker panel modifications.
measure: Performance of the Syantra DX Breast Cancer test in prediction of molecular subtype of breast cancer as assessed by pathology
time frame: through completion of the study, approximately eighteen months
description: Correlate the performance of the test to molecular characterizations of identified cancers as assessed by pathology of tissue from biopsy or resection.
arm group label: Investigational Population
description: Suspected Invasive Breast Cancer (any size) or DCIS (pre-invasive) are of particular interest. Women with abnormal screening mammograms (R3-5) recalled for further investigation.
Inclusion criteria
Women with suspected Invasive Breast Cancer (tumours of any size and/or DCIS).
Individuals with an abnormal or suspicious screening mammogram recalled for further evaluation.
Suspected Invasive Breast Cancer (tumours of any size and/or DCIS).
Willing to give written Informed Consent and provide whole blood samples
Age 30-75 years
Exclusion criteria
Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy)
Inoperable (T4 category) or inflammatory breast cancer
Previous history of cancer previously at any site
Previous history of breast cancer
Concomitant or other concurrent anti-cancer therapy
Male
No histopathological diagnosis
arm group label: Borderline (Atypica and LCIS) Population
description: Women with borderline pathological B3 lesions (suspected atypia Ductal or Lobular and benign proliferative disease without DCIS or invasion) Inclusion criteria
Abnormal screening mammogram with suspected benign breast disease or proliferative changes
Willing to give Written Informed Consent and provide whole blood samples
Aged 30-75 years
Exclusion criteria
Existing cancer diagnosis
Male
Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy)
Previous history of any cancer
Previous history of breast cancer
Concomitant or other concurrent anti-cancer therapy
arm group label: Control Population
description: Healthy Controls Inclusion criteria
Normal breast examination - No cancer detected/suspected by physical exam, diagnostic radiology or screening mammography
Willing to give Written Informed Consent and provide whole blood samples
Aged 30-75 years
Exclusion criteria
Cancer diagnosis
Male
Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy)
Previous history of any cancer
Concomitant or other concurrent anti-cancer therapy
intervention type: Diagnostic Test
intervention name: Syantra DX Breast Cancer
description: Blood test for detecting the presence of breast cancer.
arm group label: Borderline (Atypica and LCIS) Population
arm group label: Control Population
arm group label: Investigational Population
Whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Self-identified
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nigel Bundred, MD
role: Principal Investigator
affiliation: Manchester University NHS Foundation Trust
last name: Cliona Kirwin, MD
role: Study Director
affiliation: Manchester University NHS Foundation Trust
last name: Hayley Brooks
phone: 0161 291 4045
email: Hayley.brooks@mft.nhs.uk
last name: Linda Bailey
phone: 0161 291 4492
email: linda.bailey3@mft.nhs.uk
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No