ESTIMation of the ABiLity of Prophylactic Central Compartment Neck Dissection to Modify Outcomes in Low-risk Differentiated Thyroid Cancer (NCT03570021)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (12 items).
Location: Gustave Roussy — Villejuif, Val de Marne
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Tumors \> 40 mm (cT3) or ≤ 10 mm
- Tumors with extrathyroidal extension suspected or obvious on the pre-operative work-up or intra-operatively (cT3T4)
- Metastatic neck lymph nodes or suspicious neck nodes on pre- operative ultrasound (cN1); for suspicious nodes, FNAB cytology and thyroglobulin assay on the needle washout fluid will be performed
- Metastatic neck lymph nodes found during the thyroidectomy and confirmed with intra-operative frozen section analysis
- Medullary thyroid carcinoma on FNAB cytology and/or with basal serum calcitonin \>50 pg/ml
- Preoperative or intra-operative suspicion of non-papillary thyroid carcinoma or aggressive histopathological subtype or poorly differentiated carcinoma
- Distant metastases (M1) apparent pre-operatively (found due to symptoms or fortuitously; no specific pre-operative work-up will be performed, however, in accordance with current clinical practice)
- Recurrent nerve paralysis visualized on systematic pre-operative laryngoscopy and/or abnormal preoperative serum calcium
- Pregnant or breast feeding women
- Participation in another therapeutic clinical trial within one year from study entry
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (21 Sites)
- Gustave Roussy — Villejuif, Val de Marne
- CHU d'Angers — Angers,
- Hôpital Saint André — Bordeaux,
- Institut Bergonié — Bordeaux,
- Groupement Hospitalier Est — Bron,
- Centre François Baclesse — Caen,
- Jean Perrin — Clermont-Ferrand,
- Centre Georges François Leclerc — Dijon,
- CH de Haguenau — Haguenau,
- CHU Lille, Hôpital Claude Huriez — Lille,
- CHU Nimes — Nîmes,
- CHU de Poitiers — Poitiers,
- CHU Reims - Hôpital Robert Debré — Reims,
- Institut Godinot — Reims,
- Centre Henri Becquerel — Rouen,
- Institut de Cancérologie Strasbourg — Strasbourg,
- Institut Claudius Régaud — Toulouse,
- CHU de Toulouse Hôpital Larrey — Toulouse,
- CHRU Nancy - Hôpitaux de Brabois — Vandœuvre-lès-Nancy,
- CHU de Pointe à Pitre — Les Abymes,
- Clinique Saint Vincent — Réunion,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.