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This study is a multicenter observational study. Patients receive neoadjuvant therapy with RET inhibitors in the real world, and those who can undergo surgery after neoadjuvant therapy receive surgical treatment. The aim of the study is to determine the efficacy and safety of RET inhibitors for neoadjuvant therapy in locally advanced RET-altered thyroid cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| None MTC | DTC, PDTC and ATC patients with RET fusions. |
| |
| MTC | MTC patients with RET mutations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RET Inhibitor | Drug | RET inhibitors for neoadjuvant treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| R0/1 resection rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate, ORR | 1 year | |
| Disease Control Rate,DCR | 1 year | |
| Time to objective response,TTR |
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Inclusion Criteria:
Patients voluntarily join this study and sign an informed consent form;
Age: ≥ 14 years old, male or female not limited;
Locally advanced thyroid cancer diagnosed by histopathology, including papillary thyroid carcinoma, medullary thyroid carcinoma, follicular thyroid carcinoma, poorly differentiated/poorly differentiated thyroid carcinoma, etc;
RET alterations, including fusion and mutations;
The definition of locally advanced thyroid cancer meets at least one of the following criteria:
At least one measurable lesion;
For patients with distant metastasis, researchers need to determine whether patients would benefit from surgery;
Patients voluntarily undergo tumor tissue biopsy/surgery during enrollment and withdrawal;
Normal function of major organs.
Exclusion Criteria:
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Patients with locally advanced thyroid cancer and RET alterations, who require RET inhibitor treatment and surgery after neoadjuvant therapy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan Univeristy Shanghai Cancer Center | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Surgery |
| Procedure |
Operable patients receive surgery after neoadjuvant therapy |
|
| 1 year |
| Progression Free Survival,PFS | 5 years |
| Overall Survival,OS | 5 years |
| Adverse Events | During RET inhibitor treatment, up to 5 years |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |