A Study to Identify Breast Cancer (IDBC)

NCT04495244 | Unknown DMC

• 1 other identifier: 241391
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

Detection, blood test, clinical assay

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Modulate test methodology to account for differences between retrospective and prospective samples

  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

  through completion of the study, approximately eighteen months

Study Arms (3)

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

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

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

Interventions

Syantra DX Breast Cancer DIAGNOSTIC_TEST

Blood test for detecting the presence of breast cancer.

Borderline (Atypica and LCIS) Population; Control Population; Investigational Population

Eligibility Criteria

• Age: 30 Years - 75 Years
• Gender Eligibility Details: Self-identified
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Syantra Inc.: lead

Study Sites (1)

Wythenshawe Hospital, Southmoor Road

Manchester, M23 9LT, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

Study Officials

• Nigel Bundred, MD

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Cliona Kirwin, MD

  Manchester University NHS Foundation Trust

  STUDY DIRECTOR

Central Study Contacts

Hayley Brooks

CONTACT

0161 291 4045; Hayley.brooks@mft.nhs.uk

Linda Bailey

CONTACT

0161 291 4492; linda.bailey3@mft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 31, 2020
• Study Start: January 24, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: July 31, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)