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Not Yet Recruiting NCT07612293

STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection

Conditions: Thyroid Gland Medullary Carcinoma

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Jonsson Comprehensive Cancer Center

Location: UCLA / Jonsson Comprehensive Cancer Center Los Angeles California

Summary

This clinical trial studies how well thyroid lobectomy with ipsilateral central neck dissection works to treat medullary thyroid cancer (MTC) in patients without a germline RET mutation (sporadic). Currently, sporadic and germline RET (rearranged during transfection) mutation positive MTCs that are limited to the thyroid are managed in the same way, complete surgical removal of the entire thyroid gland (total thyroidectomy) with surgical removal of lymph nodes and other tissues on both sides of the neck (bilateral central neck dissection). Total thyroidectomy and bilateral central neck dissection carry a high risk of complications, and total thyroidectomy requires patients to take lifelong thyroid hormone replacement therapy, which can impact quality of life. Research has shown that patients with sporadic MTC do not have a high risk of developing MTC in the remaining normal thyroid tissue and that they may be able to be managed differently than patients with germline RET mutations. Thyroid lobectomy with ipsilateral central neck dissection is a surgical procedure which removes only the lobe of the thyroid gland that is affected by cancer as well as the lymph nodes and other tissues from the affected side of the neck. Thyroid lobectomy with ipsilateral central neck dissection may be a safer, more tolerable, and/or more effective way to treat sporadic MTC.

Eligibility Criteria

Inclusion Criteria: * Male or female ≥ 18 years of age at time of diagnosis * Documentation of a medullary thyroid cancer diagnosis as evidenced by: * Thyroid fine needle aspiration biopsy with cytologist consistent with medullary thyroid cancer * Indeterminate cytology from thyroid fine needle aspiration with elevated serum calcitonin OR thyroid molecular testing consistent with medullary thyroid cancer * Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study * Appropriate candidate for thyroid lobectomy and/or total thyroidectomy Exclusion Criteria: * Indication for total thyroidectomy unrelated to medullary thyroid cancer: * Graves' disease * Symptomatic multinodular goiter * Contralateral symptomatic benign nodules * Ultrasound findings consistent with: * Cervical lymphadenopathy involving lateral neck or contralateral central neck * Suspicious thyroid nodules \> 1 cm that are Thyroid Imaging Reporting and Data Systems 2 (TIRADS2) or higher without fine needle aspiration (FNA) * Pure cystic and spongiform nodules do not require FNA * Patients with nodules that meet criteria above can elect to undergo FNA, and may enroll in study if benign cytology is noted * Identification of germline RET mutation on preoperative genetic testing

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07612293). StuddyBuddy aggregates publicly available trial information.