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The role of imprinted genes in the preoperative diagnosis of breast tumors

The role of imprinted genes in the preoperative diagnosis of breast tumors

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108235
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast tumor

Interventions

Gold Standard:Final Diagnostic Basis: Comprehensive pathological evaluation of the surgically resected specimen, including: Histological type: Classified according to the WHO classification of breast
Index test:Allelic expression status of the imprinted genes GNAS, GRB10, and SNRPN.

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: This study prospectively enrolls patients who have not undergone surgery, meeting the following criteria: 1. Age >= 18 years, regardless of gender; 2. Meeting the indications for biopsy as per the Breast Imaging Reporting and Data System (BI-RADS) outlined in the 2013 ACR guidelines; 3. No prior history of radical breast surgery, radiotherapy, neoadjuvant chemotherapy, or targeted therapy; 4. Non-pregnant and non-lactating patients; 5. Voluntary participation and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. RNA degradation in patient CNB or FNA samples, or tumor purity below the minimum detection threshold of the QCIGISH technology. 2. Incomplete clinical information (Note: Patients without immediate surgical indications or those who did not undergo surgery may be followed up).

Design outcomes

Primary

MeasureTime frame
sensitivity;specifity;Accuracy;

Countries

China

Contacts

Public ContactYifeng Zhang

Shanghai General Hospital

yifengzhang0108@163.com+86 135 6484 3665

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026