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Evaluating the Molecular Landscape by Multigene Testing in Preoperative BRAF V600E-Positive Thyroid Nodules: A Multicenter Study

Evaluating the Molecular Landscape by Multigene Testing in Preoperative BRAF V600E-Positive Thyroid Nodules: A Multicenter Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112247
Enrollment
Unknown
Registered
2025-11-11
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Thyroid nodules

Interventions

BRAF V600E-positive group:None

Sponsors

Renji Hospital, School of Medicine in Shanghai Jiao Tong University, Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.The initial ultrasound examination showed at least one thyroid nodule, and fine-needle aspiration was performed in the hospital. There were cytological test results and molecular test results, and the preoperative BRAF V600E test result was positive 2. After assessment by a surgeon, there are surgical indications. The surgical indications include but are not limited to one of the following situations: 1) Thyroid nodules may compress or affect appearance; 2) The patient subjectively requests surgical removal of the nodule; 3) Fine needle aspiration biopsy (FNAB) does not determine the benign or malignant nature of the nodule, that is, it is classified as Class III or IV by Bethesda, and diagnostic surgery is required. 4) After evaluation by the researchers, there are other surgical indications. 3. There should be sufficient paraffin-embedded tissue or section samples after thyroid surgery available for multi-gene molecular detection 4. Age >=18 years old 5. The specimens from thyroid surgery resection have corresponding postoperative routine pathological diagnosis reports

Exclusion criteria

Exclusion criteria: 1.Patients without postoperative histopathological diagnosis results 2. Patients without preoperative FNA puncture cytological molecular test results 3. Patients who have not undergone surgical treatment in this hospital

Design outcomes

Primary

MeasureTime frame
Molecular Mutation Landscape of Thyroid Nodules;The proportion of high molecular risk group (high MRG);

Secondary

MeasureTime frame
The molecular mutation profile of samples with inconsistent preoperative and postoperative BRAF V600E test results;The proportion of intermediate molecular risk group (intermediate MRG);

Countries

China

Contacts

Public ContactZhuoying Wang

Renji Hospital, School of Medicine in Shanghai Jiao Tong University, Shanghai

wangzhuoying@renji.com+86 21 5875 2345

Outcome results

None listed

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