Breast Cancer ScreeningNCT06902935
Establishment and Clinical Application of Breast Cancer Risk Prediction Model Based on Traditional Chinese Medicine Four Diagnostic Instruments and Ultrasound
An observational study of Breast Cancer Screening, run by Taizhou Hospital at 1 site in China.
Trial summary
Construct a breast cancer risk prediction model based on traditional Chinese medicine four diagnostic instruments and B-ultrasound images. Ensure that the key evaluation indicators of the model reach a high level through clinical verification, so as to contribute to accurate clinical diagnosis and treatment… Read more about this study
- Who is it for?
- Ages 30 to 75 years, women only
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations and Ultrasound diagnosis of breast cancer
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2025to 26 Apr 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast masses who come to the clinic for medical treatment
Who may be able to join
- Female patients aged between 30 and 75.
- Patients who have a mass detected by US examination, need to undergo surgery or needle biopsy, and obtain a definite pathological result.
- Patients who have obtained complete identification results of tongue, pulse, face, and constitution through the traditional Chinese medicine four diagnostic instruments.
Who cannot join
- 1. Patients with severe heart, liver, or kidney insufficiency, or other serious systemic diseases.
- 2. Patients with a history of other malignant tumors. 3. Cases with poor - quality B - ultrasound images. 4. Cases with an unclear pathological diagnosis. 5. Patients with obvious lesions on the face, in the oral cavity, or on the tongue that may affect the measurement results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Taizhou Central Hospital (Affiliated Hospital of Taizhou University)
Taizhou, Zhejiang, 318000
sunmengwei, 008619804632150, 935275820@qq.com
About this study
Construct a breast cancer risk prediction model based on traditional Chinese medicine four diagnostic instruments and B-ultrasound images. Ensure that the key evaluation indicators of the model reach a high level through clinical verification, so as to contribute to accurate clinical diagnosis and treatment decision-making.
- Conditions
- Breast Cancer Screening
- Being tested
- Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations, Ultrasound diagnosis of breast cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of Breast Cancer by Traditional Chinese Medicine Four ExaminationsDiagnostic test
The Daosheng TCM Four-Diagnostic Instrument (DS01-A) comprehensively collects patients' TCM four-diagnostic information, covering tongue (e.g., overall color, coating color/thickness/greasiness, tooth marks, etc.), pulse (e.g., position, force, rhythm, etc.), face (e.g., overall color, luster, lip color/dryness, etc.) and constitution scores (quantifying 9 constitutions via the TCM Constitution Classification Table).
Ultrasound diagnosis of breast cancerDiagnostic test
Professional ultrasound physicians use B - ultrasound equipment of the same model to accurately collect detailed parameters of breast masses according to a standardized process. These parameters include shape (oval, round, irregular), orientation (parallel, non - parallel), margin (smooth, non - smooth, with non - smooth including blurred, angular, microlobulated, spiculated, etc.), echo pattern (anechoic, hyperechoic, complex cystic - solid echo, hypoechoic, isoechoic, heterogeneous echo), posterior echo characteristics (no change, enhancement, shadowing, mixed), calcification (microcalcification and coarse calcification within the mass, calcification outside the mass, intraductal), and vascular supply (no blood supply, internal blood supply, marginal blood supply), etc.
| Study group | Role | What they receive |
|---|---|---|
| Case group | The patients included in the group are those whose pathological results of breast masses are malignant. Receives: Diagnostic Test: Diagnosis of Breast Cancer by Traditional Chinese Medicine Four Examinations | |
| Control group | The patients included in this group are those whose pathological results of breast masses are benign. Receives: Diagnostic Test: Ultrasound diagnosis of breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tongue appearance collection (overall tongue color)
pale white, pale purple, light red, dark red, dark purple
Measured: through study completion, an average of 1 year
Tongue appearance collection (overall tongue coating color)
white, yellow, no tongue coating
Measured: through study completion, an average of 1 year
Tongue appearance collection (thickness of the tongue coating)
Thin tongue coating, thick tongue coating, scanty tongue coating or no tongue coating
Measured: through study completion, an average of 1 year
Pulse condition collection (pulse strength)
forceful, moderate, weak
Measured: through study completion, an average of 1 year
Pulse condition collection (pulse rhythm)
Regular, rapid intermittent pulse, slow intermittent pulse.
Measured: through study completion, an average of 1 year
Pulse condition collection (pulse rate)
Slow pulse, moderate pulse, normal pulse, rapid pulse, extremely rapid pulse.
Measured: through study completion, an average of 1 year
Collection of facial appearances (overall facial complexion)
Normal facial complexion, white complexion, yellow complexion, red complexion, cyan complexion, black complexion
Measured: through study completion, an average of 1 year
Collection of facial appearances (overall luster)
With luster, without luster
Measured: through study completion, an average of 1 year
Judgment of Constitution Score
Balanced constitution, Qi-deficiency constitution, Yang-deficiency constitution, Yin-deficiency constitution, Phlegm-dampness constitution, Damp-heat constitution, Blood-stasis constitution, Qi-stagnation constitution, Special constitution.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start26 Apr 2025 (estimated)
- Primary completion26 Apr 2027 (estimated)
- Study completion26 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer ScreeningStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Mengwei, Taizhou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902935
- Sponsor's protocol ID
- 2025L-02-012
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Clinical Application of Breast Cancer Risk Prediction Model Based on Traditional Chinese Medicine Four Diagnostic Instruments and Ultrasound
- ClinicalTrials.gov ID
- NCT06902935
- Acronym / sponsor ID
- 2025L-02-012
- Conditions
- Breast Cancer Screening
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Study start
- 26 Apr 2025 (estimated)
- Primary completion
- 26 Apr 2027 (estimated)
- Study completion
- 26 Apr 2027 (estimated)
- First posted
- 30 Mar 2025 (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.
Construct a breast cancer risk prediction model based on traditional Chinese medicine four diagnostic instruments and B-ultrasound images. Ensure that the key evaluation indicators of the model reach a high level through clinical verification, so as to contribute to accurate clinical diagnosis and treatment decision-making.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Diagnostic Test: Diagnosis of Breast Cancer by Traditional Chinese Medicine Four ExaminationsThe patients included in the group are those whose pathological results of breast masses are malignant. |
| Control group | – | Diagnostic Test: Ultrasound diagnosis of breast cancerThe patients included in this group are those whose pathological results of breast masses are benign. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast masses who come to the clinic for medical treatment
Key inclusion criteria (3 listed)
- Female patients aged between 30 and 75.
- Patients who have a mass detected by US examination, need to undergo surgery or needle biopsy, and obtain a definite pathological result.
- Patients who have obtained complete identification results of tongue, pulse, face, and constitution through the traditional Chinese medicine four diagnostic instruments.
Key exclusion criteria (2 listed)
- 1. Patients with severe heart, liver, or kidney insufficiency, or other serious systemic diseases.
- 2. Patients with a history of other malignant tumors. 3. Cases with poor - quality B - ultrasound images. 4. Cases with an unclear pathological diagnosis. 5. Patients with obvious lesions on the face, in the oral cavity, or on the tongue that may affect the measurement results.
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 |
|---|---|---|
| Diagnosis of Breast Cancer by Traditional Chinese Medicine Four ExaminationsThe Daosheng TCM Four-Diagnostic Instrument (DS01-A) comprehensively collects patients' TCM four-diagnostic information, covering tongue (e.g., overall color, coating color/thickness/greasiness, tooth marks, etc.), pulse (e.g., position, force, rhythm, etc.), face (e.g., overall color, luster, lip color/dryness, etc.) and constitution scores (quantifying 9 constitutions via the TCM Constitution Classification Table). | Diagnostic test | Case group |
| Ultrasound diagnosis of breast cancerProfessional ultrasound physicians use B - ultrasound equipment of the same model to accurately collect detailed parameters of breast masses according to a standardized process. These parameters include shape (oval, round, irregular), orientation (parallel, non - parallel), margin (smooth, non - smooth, with non - smooth including blurred, angular, microlobulated, spiculated, etc.), echo pattern (anechoic, hyperechoic, complex cystic - solid echo, hypoechoic, isoechoic, heterogeneous echo), posterior echo characteristics (no change, enhancement, shadowing, mixed), calcification (microcalcification and coarse calcification within the mass, calcification outside the mass, intraductal), and vascular supply (no blood supply, internal blood supply, marginal blood supply), etc. | Diagnostic test | Control group |
Primary outcome
Tongue appearance collection (overall tongue color)
Time frame: through study completion, an average of 1 year
pale white, pale purple, light red, dark red, dark purple
Tongue appearance collection (overall tongue coating color)
Time frame: through study completion, an average of 1 year
white, yellow, no tongue coating
Tongue appearance collection (thickness of the tongue coating)
Time frame: through study completion, an average of 1 year
Thin tongue coating, thick tongue coating, scanty tongue coating or no tongue coating
Pulse condition collection (pulse strength)
Time frame: through study completion, an average of 1 year
forceful, moderate, weak
Pulse condition collection (pulse rhythm)
Time frame: through study completion, an average of 1 year
Regular, rapid intermittent pulse, slow intermittent pulse.
Pulse condition collection (pulse rate)
Time frame: through study completion, an average of 1 year
Slow pulse, moderate pulse, normal pulse, rapid pulse, extremely rapid pulse.
Collection of facial appearances (overall facial complexion)
Time frame: through study completion, an average of 1 year
Normal facial complexion, white complexion, yellow complexion, red complexion, cyan complexion, black complexion
Collection of facial appearances (overall luster)
Time frame: through study completion, an average of 1 year
With luster, without luster
Judgment of Constitution Score
Time frame: through study completion, an average of 1 year
Balanced constitution, Qi-deficiency constitution, Yang-deficiency constitution, Yin-deficiency constitution, Phlegm-dampness constitution, Damp-heat constitution, Blood-stasis constitution, Qi-stagnation constitution, Special constitution.
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 30 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Screening, run by Taizhou Hospital at 1 site in China.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 sunmengwei (008619804632150, 935275820@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tongue appearance collection (overall tongue color) (time frame: through study completion, an average of 1 year). The study lists 9 primary outcomes in all. 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 30 Mar 2025.