STAGE-MTC Trial Thyroid Lobectomy With Ipsilateral Central Neck Dissection

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 2, 2031 → Sep 2, 2032
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Record History

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  1. Notable Primary completion pushed from Sep 2, 2031 to Sep 2, 2032 Show 6 more changesShow less
    • Start date: Sep 2, 2026 to Sep 2, 2027
    • Study completion pushed from Apr 21, 2032 to Sep 2, 2033
    • Interventions: Biospecimen Collection (Procedure), FDG-Positron Emission Tomography and Computed Tomography Scan (Procedure), Ga-68 PET/CT Scan… to Biospecimen Collection (Procedure), FDG-Positron Emission Tomography and Computed Tomography Scan (Procedure), Ga-68 PET/CT Scan…
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
  2. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07612293
Lead Sponsor Jonsson Comprehensive Cancer Center
Collaborators: Eli Lilly and Company
Conditions
(from sponsor)
Thyroid Gland Medullary Carcinoma
Related terms Carcinoma, Medullary
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov