Clinical trial NCT04495244: A Study to Identify Breast Cancer (IDBC)
Official title: Investigation of a Novel Blood Test to Identify Breast Cancer (IDBC)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Female
Keywords: Detection, blood test, clinical assay
Lead sponsor: Syantra Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-31
Enrollment: 600
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Populations will be selected from women visiting the Nightingale Centre at Wythenshaw Hospital for breast cancer imaging.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria

* Aged 30-75 years
* 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

* 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
* Inoperable or inflammatory breast cancer

Primary outcomes:
measure: Performance of the Syantra DX Breast Cancer test as assessed by sensitivity and specificity
timeFrame: through completion of the study, approximately eighteen months
Secondary outcomes:
measure: Modulate test methodology to account for differences between retrospective and prospective samples
timeFrame: through completion of the study, approximately eighteen months
measure: Performance of the Syantra DX Breast Cancer test in prediction of molecular subtype of breast cancer as assessed by pathology
timeFrame: through completion of the study, approximately eighteen months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital, Southmoor Road
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Nigel Bundred, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Manchester University NHS Foundation Trust
name: Cliona Kirwin, MD
role: STUDY_DIRECTOR
References: