Recruiting

Syantra DX Breast Cancer

Sponsor:

Syantra Inc.

Code:

NCT04495244

Conditions

Breast Cancer Female

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

Syantra DX Breast Cancer

Study Details

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

Study ID

NCT04495244

Start date

Jan 24, 2019

Status verified date

Aug, 2026

Completion date

Dec 31, 2032

Anticipated

Primary completion date

Dec 31, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

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
  • Existing cancer diagnosis

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

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

Interventions

Syantra DX Breast Cancer

Blood test for detecting the presence of breast cancer.

Primary outcome measure

  • Performance of the Syantra DX Breast Cancer test as assessed by sensitivity and specificity [ Time Frame: through completion of the study. Individual participant data for primary outcome recorded about 18 months from enrollment. ]

Central Contacts and Locations

Central contacts

Natasha Jones

0161 291 4045Natasha.Jones@mft.nhs.uk

Linda Bailey

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

Locations

Alberta Cancer Research Biobank

Recruiting

Calgary, Alberta, Canada

Contacts

Shannon Brown

403-521-3604Shannon.Brown@cancercarealberta.ca

Danielle Simonot

Danielle.Simonot@cancercarealberta.ca

Principal Investigator:

Kristina Rinker, PhD

More Information

Sponsor

Syantra Inc.

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Detection, blood test, clinical assay

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Syantra Inc. on 2026-08-19.