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A prospective study to evaluate the predictive value of susceptibility gene profiles for high-risk thyroid nodules

A prospective study to evaluate the predictive value of susceptibility gene profiles for high-risk thyroid nodules

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100045546
Enrollment
Unknown
Registered
2021-04-19
Start date
2021-05-01
Completion date
Unknown
Last updated
2021-11-29

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

Conditions

High Risk Thyroid Nodules

Interventions

Gold Standard:Ultrasound-guided fine-needle aspiration (US-FNAB) can identify the nature of thyroid nodules preoperatively, provide a basis for individualized precise treatment of thyroid diseases, an
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Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: To identify and improve the susceptibility gene profile of papillary thyroid carcinoma 1.Subjects who underwent thyroid surgery in the General Surgery Department of Beijing Hospital from January 2021 to December 2026; 2.Older than 18 years at the time of diagnosis; 3.Postoperative paraffin pathology showed papillary thyroid carcinoma; 4.Undergo elective radical thyroid carcinoma; 5.The subjects and their family members can understand and are willing to participate in this clinical study, and sign the informed consent. To evaluate the value of susceptibility gene profile in early warning of thyroid high-risk nodules 1.From January 2021 to December 2026, I received ultrasound-guided fine-needle aspiration in Beijing Hospital and TBSRTC pathology was grade III or IV thyroid nodules with somatic mutations of pre-existing thyroid carcinoma (e.g. BRAF V600E, TERT promoter, KRAS G12S, NRAS G12D, HRAS Q61R) negative subjects; 2.Older than 18 years at the time of diagnosis; 3.Ultrasonography showed signs of malignancy or abnormal ultrasonography of cervical lymph nodes; 4.The subjects and their family members can understand and are willing to participate in this clinical study, and sign the informed consent.

Exclusion criteria

Exclusion criteria: To identify and improve the susceptibility gene profile of papillary thyroid carcinoma 1.Subjects with cognitive or mental disorders; 2.Subjects who have undergone thyroid surgery or other neck surgery before surgery; 3.Patients with heart, brain, lung, liver, kidney dysfunction or other serious diseases; 4.Subjects who had undergone preoperative ultrasound ablation of thyroid cancer; 5.Subjects with distant tumor metastasis; 6.Subjects who have participated in or are participating in other clinical trials within 4 weeks prior to enrollment; 7.Pre-existing anemia or depression; 8.Patients with other systemic malignancies 9.Pregnant or lactating women; 10.The researcher considered that the patient with other conditions was not suitable to participate in the study. To evaluate the value of susceptibility gene profile in early warning of thyroid high-risk nodules 1.Subjects with cognitive or mental disorders; 2.With bleeding tendency, significantly prolonged bleeding and coagulation time, significantly reduced prothrombin activity or subjects who take anticoagulants for a long time and are not suitable for fine needle puncture; 3.Patients with heart, brain, lung, liver, kidney dysfunction or other serious diseases; 4.Subjects who have undergone thyroid ultrasound ablation; 5.Subjects with distant tumor metastasis; 6.Subjects who have participated in or are participating in other clinical trials within 4 weeks prior to enrollment; 7.Pre-existing anemia or depression; 8.Complicated with other systemic malignancies; 9.Pregnant or lactating women; 10.The researcher thinks that the subject is not suitable to participate in this study because of other conditions.

Design outcomes

Primary

MeasureTime frame
Thyroid imaging reporting and data system;Thyroid fine needle puncture cytology report;The pathological report;Susceptibility gene;incidence of papillary thyroid carcinoma;

Countries

China

Contacts

Public ContactMiao Gang

Beijing Hospital

miaogang72@hotmail.com+86 13552959562

Outcome results

None listed

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