An observational study in Breast Disease, sponsored by Ma Zhe. Completed at 1 site in China. Open to female participants aged 30 Years to 76 Years. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by Ma Zhe · Observational
Among 21 studies in Breast Diseases with a site in China — 8 open to participants now, 11 under way, 3 of them phase 3. Breast Diseases · China.
Among the 21 studies in Breast Diseases with a site in China, this one is the 10th largest by enrollment of the 10 observational ones that give a count, is one of 3 that started in 2021, is one of 10 observational ones, and was the 12th registered.
148 studies on the registry are indexed under Breast Diseases; 26 are open to participants now.
Browse Breast Diseases studies →8 of the 21 studies in Breast Diseases with a site in China are open now. Recruiting first, the newest first:
Huazhong University of Science and Technology · Sites in China
Ages 18–80 · Women only · Healthy volunteers
Peking Union Medical College Hospital · Sites in China
Ages 18–75 · Women only · Healthy volunteers
Fujian Cancer Hospital · Sites in China
Ages 18+ · Women only
Ensem Therapeutics · Sites in China, United States
Ages 18+
FangYi · Sites in China
Ages 18+ · Women only · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 20 Breast Diseases studies recruiting now, 14 (70%) set no upper age limit and 2 (10%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 30 Years to 76 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 6 · Phase 3 5
First in 2009; this study’s year is marked. 3 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 85 is below the median of 213 across 50 observational studies indexed under Breast Diseases.
Median enrollment 280 across the 11 interventional studies, 475 across the 10 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 21 have an industry lead sponsor. The 10 most frequent:
Ma Zhe is the lead sponsor of 8 studies on the registry; none are open to participants now.
Ma Zhe has 3 studies filed under Breast Diseases — fewer than ten, so there is no comparison to draw.
3 of the studies in Breast Diseases with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04784715Phase 3AstraZenecaTrastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | 2027-05-03 |
| NCT07500428Peking Union Medical College HospitalConstruction of a Benchmark for Breast Ultrasound AI Interpretation and Performance Evaluation of Multimodal AI Models | 2026-12-01 |
| NCT06993844Ensem TherapeuticsPhase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors | 2027-06-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 21 studies in Breast Diseases with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Objective: To explore the potential association between the multimodal ultrasound characteristics and pathological classification of BI-RADS category 4 breast lesions, so as to clarify the diagnostic characteristics of multimodal ultrasound in different pathological types BI-RADS category 4 breast lesions.
Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.
Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: no intervention
Other: no intervention
Other: no intervention
Other: no intervention
Other: no intervention
no intervention
elasticity imaging/B-mode ratio
The ratio of lesion length on strain elastography images to lesion length on grayscale images
Time frame: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
shear wave velocity
Shear wave velocity values at the hardest point of the lesion and surrounding tissues
Time frame: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
strain ratio
The ratio of average strain between surrounding tissues at the same depth and the lesion
Time frame: Immediately record the elastic modulus value after the patient receives routine ultrasound and shear wave elastography
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2021 to primary completion in Mar 2023, 16 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ma Zhe