Breast Cancer FemaleIDBCNCT04495244
A Study to Identify Breast Cancer (IDBC)
An observational study of Breast Cancer Female, run by Syantra Inc. at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Syantra DX Breast Cancer
- How many people
- 10,000 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 24 Jan 2019to 31 Dec 2032
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Populations will be selected from women visiting the actively recruiting sites for breast cancer screening.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
United Kingdom2 sites, 2 recruiting
- Recruiting
North Manchester General Hospital
Manchester, M23 9LT
Natasha Jones, Natasha.Jones@mft.nhs.uk
Nigel Bundred
- Recruiting
Wythenshawe Hospital, Southmoor Road
Manchester, M23 9LT
Natasha Jones, Natasha.Jones@mft.nhs.uk
Nigel Bundred, MD
Canada1 site, 1 recruiting
- Recruiting
Alberta Cancer Research Biobank
Calgary, Alberta
Shannon Brown, 403-521-3604, Shannon.Brown@cancercarealberta.ca
Danielle Simonot, Danielle.Simonot@cancercarealberta.ca
About this study
Official title: 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.
Read the detailed description
The current project is aimed at validating Syantra DX Breast Cancer in a screening population. 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 provide a blood sample around the time of a screening mammogram. Some women have received an abnormal mammography report, and have been classified under the UK Royal College of Radiologists Breast Group (RCRBG) or BI-RADS 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/BI-RADs, biopsy and pathology data to determine performance, and statistics will be calculated.
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.
- Conditions
- Breast Cancer Female
- Being tested
- Syantra DX Breast Cancer
- Keywords
- Detection, blood test, clinical assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Syantra DX Breast CancerDiagnostic test
Blood test for detecting the presence of breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: Syantra DX Breast Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through completion of the study. Individual participant data for primary outcome recorded about 18 months from enrollment.
Secondary outcomes (2)
Modulate test methodology to account for differences between retrospective and prospective samples
Determine the sensitivity and specificity of the assay with biomarker panel modifications.
Measured: 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.
Measured: through completion of the study, approximately eighteen months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start24 Jan 2019
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Syantra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary
- Responsible party
- Sponsor
- Investigators
- Nigel Bundred, MD, Principal investigator, Manchester University NHS Foundation TrustCliona Kirwin, MD, Study director, Manchester University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495244
- Sponsor's protocol ID
- 241391
- Acronym
- IDBC
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2020
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Novel Blood Test to Identify Breast Cancer (IDBC)
- ClinicalTrials.gov ID
- NCT04495244
- Acronym / sponsor ID
- IDBC / 241391
- Conditions
- Breast Cancer Female
- Keywords
- Detection, blood test, clinical assay
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Syantra Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 31 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 screening population. 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 provide a blood sample around the time of a screening mammogram. Some women have received an abnormal mammography report, and have been classified under the UK Royal College of Radiologists Breast Group (RCRBG) or BI-RADS 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/BI-RADs, biopsy and pathology data to determine performance, and statistics will be calculated.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational Population | – | Diagnostic Test: Syantra DX Breast CancerSuspected 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 | – | Diagnostic Test: Syantra DX Breast CancerWomen 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 | – | Diagnostic Test: Syantra DX Breast CancerHealthy 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 |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Populations will be selected from women visiting the actively recruiting sites for breast cancer screening.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Syantra DX Breast CancerBlood test for detecting the presence of breast cancer. | Diagnostic test | Borderline (Atypica and LCIS) Population, Control Population, Investigational Population |
Primary outcome
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.
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.
2 secondary outcomes
Modulate test methodology to account for differences between retrospective and prospective samples
Time frame: 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
Time frame: through completion of the study, approximately eighteen months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nigel Bundred, MD principal investigator
Manchester University NHS Foundation Trust
Cliona Kirwin, MD study director
Manchester University NHS Foundation Trust
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Syantra Inc. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Canada, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasha Jones (0161 291 4045, Natasha.Jones@mft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.