Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2019-01-24
2022-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Investigational Population
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
Syantra DX Breast Cancer
Blood test for detecting the presence of breast cancer.
Borderline (Atypica and LCIS) Population
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
Syantra DX Breast Cancer
Blood test for detecting the presence of breast cancer.
Control Population
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
Syantra DX Breast Cancer
Blood test for detecting the presence of breast cancer.
Interventions
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Syantra DX Breast Cancer
Blood test for detecting the presence of breast cancer.
Eligibility Criteria
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Inclusion Criteria
* Normal breast examination - No cancer detected/suspected by physical exam, diagnostic radiology or screening mammography
* Women with suspected Invasive Breast Cancer
* Individuals with an abnormal or suspicious mammogram
* Abnormal screening mammogram with suspected benign breast disease or proliferative changes
Exclusion Criteria
* 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
* Inoperable or inflammatory breast cancer
30 Years
75 Years
FEMALE
Yes
Sponsors
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Syantra Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nigel Bundred, MD
Role: PRINCIPAL_INVESTIGATOR
Manchester University NHS Foundation Trust
Cliona Kirwin, MD
Role: STUDY_DIRECTOR
Manchester University NHS Foundation Trust
Locations
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Wythenshawe Hospital, Southmoor Road
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Hayley Brooks
Role: primary
Other Identifiers
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241391
Identifier Type: -
Identifier Source: org_study_id