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A multicenter study on pre-surgical diagnosis for indeterminate Thyroid nodules through epigenetic imprinted genes

A multicenter study on pre-surgical diagnosis for indeterminate Thyroid nodules through epigenetic imprinted genes

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058742
Enrollment
Unknown
Registered
2022-04-16
Start date
2022-04-01
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

Thyroid carcinoma

Interventions

Index test:Imprinted gene mutation or not

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. At least 18 years old with no gender limitation; 2. Thyroid nodules in line with FNA indications of ATA guidelines; 3. Have not received partial or total thyroidectomy; 4. Cytopathology of Bethesda III-V (especially Bethesda III and IV); 5. Have surgical indications and accept surgery (suspected follicular tumors especially larger ones, try to operate as far as possible); 6. The patients are willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with FNA samples RNA degradation or insufficient epithelial cells; 2. FNA cytopathology was undiagnosed (Bethesda I), clearly benign (Bethesda II) or clearly malignant (Bethesda VI); 3. Postoperative histopathology could not clearly diagnose benign and malignant tumors, or clearly diagnose metastases of other cancers; 4. Incomplete clinical information (Note: Follow-up is available for patients who have no indication for surgery and have not received surgery).

Design outcomes

Primary

MeasureTime frame
imprinted gene;sensitivity;specifity;accuracy;area under the receiver operating characteristic curve;

Countries

China

Contacts

Public ContactYifeng Zhang

Shanghai Tenth People's Hospital

27763289@qq.com+86 13564843665

Outcome results

None listed

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