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ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer

Study acronym: ESTIMABL3
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Notable Primary completion date: Oct 2025 to Dec 2026v5 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1000 to confirmed 352
    • Study sites: 1 to 21
    • Study completion date: Oct 2029 to Dec 2027
    • Eligibility criteria expanded, about 9 words
  2. Minor Primary completion date: Jun 2026 to Oct 2025
    • Study completion date: Jun 2026 to Oct 2029
    • Start date: Aug 29, 2018 to Aug 8, 2018
    v4
  3. Minor Site contact updatedv3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2018 to Aug 29, 2018
    • Site details revised
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Prospective randomized open phase III non-inferiority trial in cT1bT2N0 papillary thyroid carcinoma comparing: total thyroidectomy alone (experimental group) versus total thyroidectomy + Prophylactic Neck Dissection PND (reference group). Pre-registered patients will be randomized before surgery for tumors with class-6 cytology (Bethesda) or in the operating room after confirmation of malignancy by frozen section analysis for tumors with class-5 cytology.
Trial Details
NCT Number NCT03570021
Lead Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Conditions
(from sponsor)
Thyroid Cancer
Related terms Thyroid Neoplasms
Enrollment 352 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov