A Study to Identify Breast Cancer (IDBC) (IDBC)

Investigation of a Novel Blood Test to Identify Breast Cancer (IDBC)

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer Female
• Intervention / Treatment: Diagnostic test: Syantra DX Breast Cancer

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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Hayley Brooks; Phone Number: 0161 291 4045; Email: Hayley.brooks@mft.nhs.uk
• Study Contact Backup: Name: Linda Bailey; Phone Number: 0161 291 4492; Email: linda.bailey3@mft.nhs.uk

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 9LT
    • Recruiting
    • Wythenshawe Hospital, Southmoor Road
    • Contact: Hayley Brooks
    • Principal Investigator: Nigel Bundred, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Populations will be selected from women visiting the Nightingale Centre at Wythenshaw Hospital for breast cancer imaging.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: 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	Diagnostic test: 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	Diagnostic test: Syantra DX Breast Cancer; Blood test for detecting the presence of breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the Syantra DX Breast Cancer test as assessed by sensitivity and specificity	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.	through completion of the study, approximately eighteen months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modulate test methodology to account for differences between retrospective and prospective samples	Determine the sensitivity and specificity of the assay with biomarker panel modifications.	through completion of the study, approximately eighteen months
Performance of the Syantra DX Breast Cancer test in prediction of molecular subtype of breast cancer as assessed by pathology	Correlate the performance of the test to molecular characterizations of identified cancers as assessed by pathology of tissue from biopsy or resection.	through completion of the study, approximately eighteen months

Collaborators and Investigators

• Sponsor: Syantra Inc.
• Investigators: Principal Investigator: Nigel Bundred, MD, Manchester University NHS Foundation Trust; Study Director: Cliona Kirwin, MD, Manchester University NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Detection, blood test, clinical assay
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 241391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No