Clinical trial · Observational
A Study to Identify Breast Cancer (IDBC)
Investigation of a Novel Blood Test to Identify Breast Cancer (IDBC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Syantra DX Breast Cancer | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Investigational Population
- description
- 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
- interventionNames
- Diagnostic Test: Syantra DX Breast Cancer
- label
- Borderline (Atypica and LCIS) Population
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available